BADANIA KLINICZNE PROWADZONE W POLSCE (stan na 03.01.2025)

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REKRUTACJA ZAKOŃCZONA


An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer - NCT04577833

https://clinicaltrials.gov/ct2/show/NCT04577833

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REKRUTACJA ZAKOŃCZONA


A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors - NCT03729596


Retifanlimab (previously known as MGA012) is an investigational, humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement
https://www.macrogenics.com/mga012-pd-1/


MGC018 (B7-H3)
MGC018 is an investigational antibody-drug conjugate (ADC) comprised of a humanized B7-H3 monoclonal antibody (mAb) conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. MGC018 is designed to target solid tumors expressing B7-H3.
https://www.macrogenics.com/mgc018-b7-h3/


Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)
https://www.businesswire.com/news/home/ ... inoma-SCAC


FDA Grants Priority Review for Retifanlimab for Advanced Squamous Cell Carcinoma of the Anal Canal
https://www.targetedonc.com/view/fda-gr ... anal-canal

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REKRUTACJA ZAKOŃCZONA


A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer - CONTACT-02 - NCT04446117

[https://clinicaltrials.gov/ct2/show/results/NCT04446117

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W uproszczeniu - zadaniem MDG019 jest wzmocnienia przeciwnowotworowej odpowiedzi układu odpornościowego.



W pierwszej fazie badania MDG019 był podawany, między innymi, pacjentom z mCRPC z 18 pacjentów, którzy mogli być ewaluowani, 4 odpowiedziało na leczenie, w tym 1 pacjent z rakiem prostaty - potwierdzona całkowita remisja.


REKRUTACJA ZAKOŃCZONA

A Phase 1, First-in-Human, Open-Label, Dose Escalation and Cohort Expansion Study of MGD019, a Bispecific DART® Protein Binding PD-1 and CTLA-4 in Patients With Unresectable or Metastatic Neoplasms

https://clinicaltrials.gov/ct2/show/NCT03761017




Wyniki drugiego etapu pierwszej fazy (czyli eskalacji dawki) zostaly omówione w artykule z września 2020.


Sep 20, 2020
MacroGenics Announces Presentation of MGD019 Phase 1 Data at the ESMO Virtual Congress 2020

=> MGD019 well-tolerated with early signals of activity in advanced solid tumors not typically responsive to checkpoint inhibition
=> Recommended Phase 2 dose established for MSS CRC, NSCLC expansion cohorts
(...)
MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced clinical data from the dose escalation portion of a Phase 1 clinical trial of MGD019.
The proffered paper session titled, “A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD019, an Investigational Bispecific PD-1 × CTLA-4 DART® Molecule in Patients with Advanced Solid Tumors,” was presented orally at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 20, 2020, by Dr. Manish R. Sharma, Associate Director of Clinical Research at START Midwest in Grand Rapids, Michigan.

MGD019, a bispecific PD-1 × CTLA-4 DART molecule, was designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells.

Forty-three patients were enrolled in the Phase 1 dose escalation study of MGD019 within a dose range of 0.03 – 10.0 mg/kg, administered every three weeks initially, in a population of heavily pre-treated patients representing a broad range of different types (23) of solid tumors.
There were no dose-limiting toxicities (DLTs).
A total of 28 patients were treated at doses ≥ 3.0 mg/kg administered every three weeks initially.
MGD019 was well-tolerated in patients who received less than 10 mg/kg; the most common treatment-related adverse events over this dosing range were pruritus (23.3%), arthralgia (18.6%), fatigue (18.6%), rash (18.6%), nausea (16.3%) and infusion-related reaction (16.3%). Several Grade 3 adverse events were observed at the 10.0 mg/kg level; however, none were considered dose limiting.
(...)
Of the 18 evaluable patients who received doses ≥ 3.0 mg/kg as of the July 21, 2020 cut-off date, four objective responses have been reported in this trial, including a confirmed complete response in metastatic castration-resistant prostate cancer (mCRPC), confirmed partial responses in microsatellite stable colorectal cancer (MSS CRC) and metastatic type AB thymoma, and an unconfirmed partial response in serous fallopian tube carcinoma.
(...)
http://ir.macrogenics.com/news-releases ... -data-esmo

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BADANIE ZAKOŃCZONE
Terminated by Sponsor for various factors including prolonged duration and enrollment challenges


PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) NCT03850795

https://clinicaltrials.gov/ct2/show/NCT03850795



____________EDIT (03/12/2021______________
FYI

HC-1119 = deuterowany enzalutamid

Lek deuterowany to drobnocząsteczkowy produkt leczniczy, w którym jeden lub więcej atomów wodoru zawartych w cząsteczce leku zostało zastąpionych jego cięższym, stabilnym izotopem deuteru.
Ze względu na kinetyczny efekt izotopowy, leki zawierające deuter mogą mieć znacznie niższe tempo metabolizmu, a tym samym dłuższy okres półtrwania.
-zb

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BADANIE KLINICZNE KEYNOTE-365 W DALSZYM CIĄGU PROWADZI REKRUTACJĘ



KEYNOTE-365:
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) NCT02861573


Brief Summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be nine cohorts in this study:

Cohort A will receive pembrolizumab + olaparib,
Cohort B will receive pembrolizumab + docetaxel + prednisone,
Cohort C will receive pembrolizumab + enzalutamide,
Cohort D will receive pembrolizumab + abiraterone + prednisone
Cohort E will receive pembrolizumab + lenvatinib,
Cohort F will receive pembrolizumab + lenvatinib,
Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A),
Cohort H will receive pembrolizumab/vibostolimab coformulation, and
Cohort I will receive pembrolizumab + carboplatin + etoposide in Arm 1 and carboplatin + etoposide in Arm 2.


Criteria

Inclusion Criteria:

=> For Cohorts A, B, C, D, E, G: Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology

=> For Cohorts F, H, I: Has t-NE prostate cancer defined by ≥1% neuroendocrine cells in a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrolment

=> Is able to provide tumor tissue from a site not previously irradiated as follows:
> Cohorts A, E, and G: must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC;
> Cohort B: must provide an archival tumor tissue sample or tumor tissue from a newly obtained core or excisional biopsy from soft tissue if the lesion is clinically accessible;
> Cohorts C and D with soft tissue disease: must provide a core or excisional biopsy from a soft tissue lesion if clinically accessible within 1 year of screening and after developing mCRPC and an archival specimen if available; and
> Cohorts F, H, and I must provide a core or excisional biopsy from soft tissue or a bone biopsy.

Participants with bone metastasis only must provide an archival tumor tissue specimen

=> Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following:
> PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL;
> radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; > radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression

=> Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM).
Treatment with luteinizing hormone-releasing hormone agonists or antagonists for all Cohorts must have been initiated ≥4 weeks prior to first dose of study therapy and must be continued throughout the study

> For Cohort A: Has received docetaxel for mCRPC.
Prior treatment with 1 other chemotherapy for mCRPC is allowed.
Up to 2 second-generation hormonal manipulations (e.g., abiraterone acetate and/or enzalutamide) are allowed. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to day 1 of Cycle 1

> For Cohort B: Has received prior treatment with either abiraterone acetate or enzalutamide (but not both) in the prechemotherapy mCRPC state. Participants in Cohort B must have received at least 4 weeks of either abiraterone or enzalutamide treatment (but not both) who failed treatment or became intolerant of the drug

> For Cohort C: Has received prior treatment with abiraterone acetate in the pre-chemotherapy mCRPC state without prior enzalutamide. Participants in Cohort C must have received at least 4 weeks of abiraterone treatment who failed treatment or become intolerant of the drug. Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible

> For Cohort D: Has not received chemotherapy for mCRPC and has either not had prior second generation hormonal manipulation for mCRPC OR has previously been treated with enzalutamide for mCRPC and failed treatment or has become intolerant of the drug.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel.
Prior treatment with abiraterone acetate in the hormone-sensitive metastatic setting is allowed as long as there was no progression on this agent and abiraterone acetate was not discontinued due to adverse events (AEs)

> For Cohorts E, F, and H: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide or other next-generation hormonal agents [NHA]) are allowed.
Participants who received prior ketoconazole for metastatic disease may be enrolled.
If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1

> For Cohorts G and I: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide, or other NHA) are allowed.
Participants who received prior ketoconazole for metastatic disease may be enrolled. I
If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1

> For Cohorts H and I: Has aggressive disease progression manifested by progression within 6 months of starting next-generation hormonal agents (NHA) for metastatic hormone-sensitive prostate cancer (mHSPC) or mCRPC and progression within <6 cycles of docetaxel treatment for mCRPC (docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC)


Exclusion Criteria:

=> Has had prior chemotherapy, targeted small molecule therapy abiraterone treatment, enzalutamide treatment, or radiation therapy within 2 weeks prior to first dose of study therapy or who has not recovered (ie, Grade ≤1 or at baseline) from AEs due to a previously administered agent

=> Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated

For Cohort B: Has received prior treatment with docetaxel or another chemotherapy agent for metastatic prostate cancer

For Cohort C: Has received prior chemotherapy for mCRPC.
Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks elapsed from last dose of docetaxel.
Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible


Poland
MSD Polska Sp. Z o.o. Recruiting
Warsaw, Poland
Contact: Thomas Johansson 48 22ý478 43 24

https://clinicaltrials.gov/ct2/show/NCT02861573

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REKRUTACJA ZAKOŃCZONA


AMPLITUDE:
A Phase 3 Randomised Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) NCT04497844

https://clinicaltrials.gov/ct2/show/NCT04497844

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REKRUTACJA ZAKOŃCZONA

Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC
NCT04887506

https://clinicaltrials.gov/ct2/show/NCT04887506

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REKRUTACJA ZAKOŃCZONA

PSMAddition:
An Open-label, Randomised Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) NCT04720157


https://clinicaltrials.gov/ct2/show/NCT04720157

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REKRUTACJA ZAKOŃCZONA

PSMAfore: A Phase III, Open-label, Multi-Center, Randomised Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer
NCT04689828

https://clinicaltrials.gov/ct2/show/NCT04689828

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REKRUTACJA ZAKOŃCZONA


A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH (NCT04597125)

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8

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REKRUTACJA ZAKOŃCZONA


A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer - NCT04123366

https://clinicaltrials.gov/ct2/show/NCT04123366





_________________________________

Wszyscy pacjenci z przerzutowym rakiem prostaty w momencie diagnozy oraz pacjenci z progresją podczas leczenia antyandrogenami II generacji (abirateron/enzalutamid) powinni być testowani na obecność mutacji HRR.
NCCN zaleca testowanie wszystkich pacjentów z mCRPC.



HRRm Testing – Metastatic Prostate Cancer – LYNPARZA® (olaparib)

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer recommend tumor testing for HRRm for any patient with mCRPC.


WHO should be tested for HRRm?

Test all patients with advanced prostate cancer at metastatic diagnosis or upon progression with enzalutamide or abiraterone.


Test for HRR gene mutations

Using FDA-approved companion diagnostics for LYNPARZA:
- FoundationOne® CDx
- FoundationOne® Liquid CDx
- Myriad BRACAnalysis CDx®



HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

ADVERSE REACTIONS — HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients in clinical trials of LYNPARZA for PROfound were:
anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients in clinical trials of LYNPARZA for PROfound were:
decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

https://www.lynparzahcp.com/metastatic- ... sting.html

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Wykaz badań klinicznych dotyczących CaP zarejestrowanych na amerykańskiej stronie clinicaltrilas.gov aktualnie prowadzących rekrutuję w Polsce (stan na 04.02.2022).

Informacje dot. kryteriów kwalifikacyjnych poszczególnych badań znajdują się w postach powyżej (jedno badanie = jeden post).

Informacje są wprawdzie w języku angielskim, ale można je w ułamku sekundy przetłumaczyć na język polski używając Google Translate https://translate.google.com

CaP_Badania Kliniczne w PL_04.02.2022.pdf

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REKRUTACJA ZAKOŃCZONA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer - NCT04691804

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8

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REKRUTACJA ZAKOŃCZONA

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3) NCT05288166

https://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8

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BADANIA KLINICZNE PROWADZONE W POLSCE ZAREJESTROWANE NA AMERYKANSKIEJ STRONIE clinicaltrials.gov
(stan na 18.09.2022)


LISTA BADAŃ KLINICZNYCH PROWADZONYCH W POLSCE DLA PACJENTÓW z CRPC (rakiem prostaty opornym na kastrację)

ClinicalTrials_CRPC_18.09.2022_PL.pdf

LISTA BADAŃ KLINICZNYCH PROWADZONYCH W POLSCE DLA PACJENTÓW z HSCP (rakiem prostaty wrażliwym na kastrację)

ClinicalTrials_HSCP_18.09.2022_PL.pdf

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REKRUTACJA ZAKOŃCZONA

PROTEUS
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy NCT03767244

https://clinicaltrials.gov/ct2/show/NCT ... =2&rank=13

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CaP_badania kliniczne_PL_24.06.2024.pdf

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BADANIE KLINICZNE PSMACare W DALSZYM CIĄGU PROWADZI REKRUTACJĘ


An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer (PSMACare) NCT05849298


Key Inclusion criteria

- Participants must be adults ≥ 18 years of age with signed informed consent prior to participation to study
- Histologically or cytologically confirmed prostate cancer
- Participants must have ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy
- Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy
- Participants must have evidence of PSMA-positive disease as seen on a AAA517 or piflufolastat F 18 PET/CT scan at baseline as determined by Blinded Independent Central Review (BICR) based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018). Participants with M1 disease only on PSMA PET scan are allowed to participate
- Participants must have a negative conventional imaging for M1 disease.
- PSA Doubling Time (PSADT) of ≤ 10 months
- Participants must have adequate organ functions: bone marrow reserve, hepatic & renal


Key Exclusion criteria

- Prior or present evidence of metastatic disease as assessed by CT/MRI locally for soft tissue disease and whole-body radionuclide bone scan for bone disease. Exception: Participants with soft tissue pelvic disease may be eligible (e.g., participants with enlarged lymph nodes below the aortic bifurcation (N1) are eligible if the short axis of the largest lymph node is <20 mm)

- Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable with best available standard of care (incl. pads, drainage) are allowed

- Active clinically significant cardiac disease; history of seizure or condition that may pre-dispose to seizure which may require treatment with surgery or radiation therapy

- Prior therapy with:
* second generation anti-androgens (e.g., enzalutamide, apalutamide and darolutamide); CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galeterone, ketoconazole;
* radiopharmaceutical agents (e.g., Strontium-89), PSMA-targeted radioligand therapy;
* immunotherapy (e.g., sipuleucel-T);
* chemotherapy, except if administered in the adjuvant/neoadjuvant setting, completed > 2 years before randomization;
* any other investigational agents for CRPC;
* use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) or
* first-generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) within 28 days before randomization;
* radiation therapy (external beam radiation therapy [EBRT] and brachytherapy within 28 days before randomization

- Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, biological therapy or investigational therapy

Poland

Kielce, Poland, 25-640 Recruiting
Novartis Investigative Site

Krakow, Poland, 31-501 Recruiting
Novartis Investigative Site


https://clinicaltrials.gov/study/NCT058 ... d=Prostate

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REKRUTACJA ZAKOŃCZONA

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) (CAPItello280) NCT05348577
https://clinicaltrials.gov/study/NCT053 ... d=Prostate



FYI:

TRUQAP® (capivasertib) to lek przeciwnowotworowy, który blokuje aktywność białka zwanego AKT, które jest ważne dla wzrostu i przeżycia komórek. AKT często wykazuje nadmierną aktywność w komórkach nowotworowych, pomagając im rosnąć i przetrwać. Capivasertib może zatrzymać wzrost komórek nowotworowych poprzez blokowanie AKT. W badaniach laboratoryjnych i na modelach zwierzęcych wykazano jego skuteczność w ograniczaniu wzrostu komórek nowotworowych.

TRUQAP® (capivasertib) jest obecnie stosowany w kombinacji z fulvestrantem w przypadku lokacie zaawansowanego lub przerzutowego HR dodatniego, HER2 negatywnego raka piersi.


Poniżej zamieszczam australijską ulotkę leku Truqap:

TRUQAP_capivasertib .pdf

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A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-PR01) NCT06120491


Inclusion Criteria:

- Male ≥ 18 years of age
- Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
- Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
- Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to randomisation
- ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
- Provision of FFPE tumour tissue sample and blood sample (for ctDNA)
- Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility
- Adequate organ and bone marrow function as described in study protocol
- Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
- Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.


Exclusion Criteria:

- Participants with a history of MDS/AML or with features suggestive of MDS/AML
- Participants with any known predisposition to bleeding
- Any history of persisting (> 2 weeks) severe cytopenia
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
- History of another primary malignancy, with exceptions
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention
- Cardiac criteria, including history of arrythmia and cardiovascular disease
- Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions:
- Prior treatment within 14 days with blood product support or growth factor support.
- Participants who are unevaluable for both bone and soft tissue progression


Poland

Bydgoszcz, Poland, 85-796 recruiting
Research Site

Koszalin, Poland, 75-581 recruiting
Research Site

Poznań, Poland, 61-731 recruiting
Research Site

Rzeszów, Poland, 35-001 recruiting
Research Site

Warszawa, Poland, 04-073 recruiting
Research Site

Wrocław, Poland, 53-329 recruiting
Research Site

Żory, Poland, 44-240 recruiting
Research Site


https://clinicaltrials.gov/study/NCT061 ... d=Prostate

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A Phase 3 Randomized, Open-label Study of MK-5684 (Opevesostat) Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy NCT06136624


Inclusion Criteria:

- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
- Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
- Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
- Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and - has had progressive disease (PD) during or after treatment
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
- Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
- Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
- Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
- If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment
- Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
- Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
- Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: - EITHER be abstinent OR must agree to use male condom


Exclusion Criteria:

- Has a gastrointestinal disorder that might affect absorption
- Has a history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level
- Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
- Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
- Has a history of clinically significant ventricular arrhythmias
- Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
- Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications
- Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate) within 4 weeks before the date of randomization
- Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization
- Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
- Has received colony-stimulating factors within 28 days before the date of randomization
- Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
- Has a "superscan" bone scan
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has an active infection requiring systemic therapy
- Has concurrent active HBV or known active HCV infection
- Has a history of long QTc syndrome
- Has any of the following at Screening Visit: hypotension (systolic BP <110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
- Is unable to swallow capsules/tablets
- Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
- Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle [Silybum marianum])
- Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention


Poland


Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796 Recruiting
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302)
Contact: Study Coordinator 48501446778

Siedlce, Mazowieckie, Poland, 08-110 Recruiting
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310)
Contact: Study Coordinator 48698826497

Kielce, Swietokrzyskie, Poland, 25-734 Recruiting
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch
Contact: Study Coordinator +48885997850


Koszalin, Zachodniopomorskie, Poland, 75-581 Recruiting
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303)
Contact: Study Coordinator 48502204953

https://clinicaltrials.gov/study/NCT061 ... d=Prostate



OPEVESOSTAT

Merck and Orion Announce Mutual Exercise of Option Providing Merck Global Exclusive Rights to Opevesostat, an Investigational CYP11A1 Inhibitor, for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Opevesostat is an oral, non-steroidal and selective inhibitor of CYP11A1 discovered and developed by Orion and is being investigated for the treatment of hormone-dependent cancers, such as prostate cancer. By inhibiting CYP11A1 activity, opevesostat is designed to suppress the production of all steroid hormones and their precursors that may activate the androgen receptor signaling pathway.

https://www.merck.com/news/merck-and-or ... istant-pr/

[zosia bluszcz]

Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) NCT06353386

Experimental: Arm A1: Opevesostat
Experimental: Arm A2: Olaparib + Opevesostat
Experimental: Arm A3: Docetaxel + Opevesostat
Experimental: Arm A4: Cabazitaxel + Opevesostat


The main inclusion criteria include but are not limited to the following:

- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
- Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
- Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
- Current evidence of metastatic disease.
- Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
- Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization.
- Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to <Grade 1 or baseline.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.



The main exclusion criteria include but are not limited to the following:

- History of pituitary dysfunction.
- Poorly controlled diabetes mellitus.
- Active or unstable cardio/cerebro-vascular disease, including thromboembolic events.
- History or family history of long corrected QT interval (QTc) syndrome.
- Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
- History or current condition of adrenal insufficiency.
- History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
- Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
- Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed.
- Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Active infection requiring systemic therapy.
- Concurrent active HBV and HCV infections


Poland

Warszawa, Mazowieckie, Poland, 02-781 Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400
Contact: Study Coordinator 48504340022

https://clinicaltrials.gov/study/NCT063 ... d=Prostate

[zosia bluszcz]

LISTA BADAŃ KLINICZNYCH DOT. CaP PROWADZONYCH W POLSCE I ZAREJESTROWANYCH NA AMERYKANSKIEJ STRONIE clinicaltrials.gov
(stan na 03.01.2025)

CaP_badania kliniczne_PL_03.01.2025.csv

[zosia bluszcz]

w Gammed w Warszawie (scyntygrafia) wybranym pacjentom proponują udział w nowym badaniu obrazowym - scyntygrafia z PSMA -t4 czyli cos jak scyntygrafia i PET PSMA razem, badanie celowane w zmiany związane z rakiem prostaty a nie ogolne, jak sama scyntygrafia.

Dzięki za powyższą informację.

Sciślej to ujmując, 3 ośrodki w Polsce:

- GAMMED w Warszawie
- CO Bydgoszcz (CO)
- WSK Wrocław, ul. Weigla 5

prowadzą nabór do badania klinicznego z zastosowaniem dożylnego znacznika izotopowego [99mTc]Tc-PSMA-T4 opatentowanego przez Narodowe Centrum Badań Jądrowych Polatom.

PL239934B1 - Derivatives of PSMA inhibitors for ⁹⁹ᵐTc labelling by HYNIC, radiopharmaceutical kit, radiopharmaceutical preparations and their use in the diagnosis of prostate cancer
Pochodne inhibitorów PSMA do znakowania 99mTc poprzez HYNIC, zestaw radiofarmaceutyczny, preparaty radiofarmaceutyczne oraz ich zastosowanie w diagnostyce raka prostaty
https://patents.google.com/patent/PL239934B1/en

Badanie ma 3 ramiona:

Ramię A:
Rak prostaty średniego ryzyka, zgodnie z definicją zawartą w najnowszej wersji amerykańskich NCCN Guidelines
Większe niż 10% ryzyko zajęcia węzłów chłonnych oceniane za pomocą nomogramu MSKCC

Ramię B:
Rak prostaty wysokiego lub bardzo wysokiego ryzyka zgodnie z definicją zawartą w najnowszej wersji amerykańskich NCCN Guidelines

Ramię C:
BCR po RP definiowane jako brak spadku PSA do niewykrywalnego poziomu lub niewykrywalne PSA po RP z późniejszym wykrywalnym wzrostem PSA w 2 lub więcej oznaczeniach
lub
BCR po radykalnej RT (definicja wg Phoenix Consensus)
lub
przerzuty wykryte w badaniach obrazowych bez utrzymywania się/nawrotu PSA
lub
objawy kliniczne sugerujące przerzuty odległe.

A Phase 2/3, Open-Label Study, to Evaluate the Feasibility and Safety of Intravenous [99mTc]Tc-PSMA-T4 in Subjects With Prostate Cancer

Inclusion Criteria:

(...)
- PS ECOG < 2
- Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6.
- Confirmatory prostate biopsy, pelvic MRI and bone scan within 1 month before screening
- Willingness to participate in this study and to obtain written informed consent.

Additional inclusion criteria for each cohort:

Cohort A:
Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer
Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients.

Cohort B:
High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer

Cohort C:
Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after RP with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases.


Exclusion Criteria:

- No histopathological confirmation of prostate cancer.
- Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer.
- Infection with hepatitis B virus (including carriers) during screening, i.e. hepatitis B positive surface antigen (HBsAg) or positive hepatitis C (anti-HCV) antibody.
- Infected with acquired immunodeficiency (HIV).
- Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2xULN.
- Renal impairment including GFR <30 ml / min.
- Within 6 months before inclusion into the study: myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.);
- Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block.
- Cerebrovascular accident, transient ischemic attack, acute stroke etc.
- Subjects with pulmonary embolism or deep vein thrombosis have been reported within the last 6 months.
- An active infection that the investigator considers precluding the patient from being included in the study, such as urinary tract infections, respiratory tract infections, and diabetes infection within the diabetic foot with osteomyelitis


Active Comparator: Cohort A - lymph node assessment in intermediate risk group
The patients will undergo [99mTc]Tc-PSMA-T4 semiWB- SPECT/CT as an additional modality to contrast-enhanced (CE) multiparametric MRI (according to PI-RADS 2.1 protocol) with additional chest and abdominal CE computed tomography and [99mTc]Tc-MDP bone scan in unfavorable risk prostate cancer patients

Active Comparator: Cohort B - general assessment (bone and lymph nodes) in high and very high-risk group
The patients will undergo [99mTc]TcPSMA-T4 semi-WB- SPECT/CT and CE multiparametric MRI (according to PI-RADS 2.1 protocol), and chest and abdomen CE computed tomography, and skeletal scintigraphy ([99mTc]Tc-MDP bone scan).


Active Comparator: Cohort C - recurrent disease after definitive treatment (radiotherapy or surgery)
The patients will undergo [99mTc]TcPSMA-T4 semiWB- SPECT/CT and the second confirmatory imaging modality or biopsy in the case of evidence on progressive disease (PSA persistence/recurrence or radiographic evidence of metastatic disease or clinical symptoms suggesting metastatic disease).



Poland

GAMMED Centrum Diagnostyczno-Lecznicze
Warszawa, Lelechowska 5, Poland, 02-351 Recruiting

Contact: GENELYTICA 513466270 k.socko@genelytica.com
Principal Investigator: Jarosław Ćwikła, Prof.


Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz, Ul. Dr Izabeli Romanowskiej 2, Poland, 85-796 Recruiting
Contact: GENELYTICA 513466270 k.socko@genelytica.com
Principal Investigator: Bogdan Małkowski, Prof


Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wrocław, Weigla 5, Poland, 53-114 Recruiting
Contact: GENELYTICA 513466270 k.socko@genelytica.com
Principal Investigator: Andrzej Kołodziejczyk, Dr

https://clinicaltrials.gov/study/NCT058 ... d=Prostate


Droga do opracowania radioznacznika PSMA-T4:

[ 99mTc]Tc-PSMA-T4—Novel SPECT Tracer for Metastatic PCa- From Bench to Clinic.pdf

Bułgarski artykuł dot. obrazowania z zastosowaniem SPECT-CT z radioznacznikiem [ 99mTc]Tc-PSMA-T4 u pacjentów z nawrotem raka prostaty:

SPECT-CT imaging with [99mTc]PSMA-T4 in patients with recurrent prostate cancer.pdf

[wowa]

NIO w Gliwicach ogłasza rekrutację do badania klinicznego „PSMA-ADJUVO” (177Lu-PSMA).


Badanie kliniczne „PSMA-ADJUVO” prowadzone pod kierownictwem Pani Profesor Darii Handkiewicz-Junak – Kierownika Zakładu Medycyny Nuklearnej we współpracy ze Specjalistami Radioterapii Onkologicznej zatrudnionymi w NIO-PIB Gliwice obejmie aż

200-stu dorosłych mężczyzn z rakiem gruczołu krokowego wysokiego lub bardzo wysokiego ryzyka, bez cech rozsiewu choroby nowotworowej w badaniach radiologicznych.

Pacjenci mogą zostać włączeni bo badania do 3 miesięcy po zakończonej radioterapii, podczas kontynuowana hormonoterapii.

W tym dwuramiennym, randomizowanym, otwartym i niekomercyjnym badaniu klinicznym prowadzonym wyłącznie w Naszym Ośrodku,

Pacjenci zostaną przydzieleni do jednej z dwóch grup- BADAWCZEJ z zastosowaniem terapii uzupełniającej 177Lu-PSMA oraz KONTROLNEJ która zostanie poddana standardowej hormonoterapii.

Badanie ma a celu potwierdzenie hipotezy badawczej w której przyjęto, że zastosowanie uzupełniającego leczenia 177Lu-PSMA, jako jednorazowej aktywności terapeutycznej, w raku gruczołu krokowego wysokiego i bardzo wysokiego ryzyka powinno związać się ze zmniejszeniem ryzyka niepowodzenia leczenia.

Rekrutacja do badania prowadzona jest przez Specjalistów Radioterapii Onkologicznej Zakładów Radioterapii i Brachyterapii Naszego Instytutu. Więcej informacji uzyskają Państwo u koordynatora badania pod numerem telefonu (32) 278-94-42 lub (32) 278-97-91.


https://badaniakliniczne.io.gliwice.pl/ ... ma-adjuvo/