Badanie kliniczne dla pacjentów z przerzutowym, hormonozależnym rakiem prostaty wysokiego ryzyka.
Wszyscy uczestnicy badania dostają Abirateron z prednizonem
plus
albo Abemacyclib, silny inhibitorem kinazy CDK4/6, (stosowany w leczeniu raka piersi),
albo placebo.
Jednym z warunków kwalifikacji brak systemowego leczenia przed randomizacją, z wyjątkiem
- maksimum 3 miesięcznej HT (bez progresji PSA/progresji wykazanej w badaniach obrazowych)
lub
- 6 cykli CHT DX w połączeniu z HT (bez progresji PSA/progresji wykazanej w badaniach obrazowych).
Na dziś nabór do tego badania klinicznego CYKLON 3 jest prowadzony jest jedynie w Lublinie oraz w Piotrkowie Trybunalskim.
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
Inclusion Criteria:
=> Adenocarcinoma of the prostate.
=> High-risk metastatic disease defined as:
- Greater than or equal to (≥)4 bone metastases and/or
- ≥1 visceral metastases
=> Androgen deprivation therapy (either medical with a luteinizing hormone-releasing hormone [LHRH] analogue or surgical castration) must have been started prior to randomization and continued throughout the study.
=> Adequate organ function
=> Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
=> Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 & 6) inhibitor
=> Development of metastatic prostate cancer in the context of castrate levels of testosterone (≤50 ng/dL)
=> Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), the following exceptions are permitted:
- Up to 3 months of androgen deprivation therapy (ADT) (when given without docetaxel) AND absence of radiographic or prostate specific antigen (PSA) progression prior to randomization
- Up to 6 cycles of docetaxel with ADT AND absence of radiographic or PSA progression prior to randomization
=> Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
=> History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
=> Uncontrolled hypertension
=> Clinically active or chronic liver disease, moderate/severe hepatic impairment
=> Known untreated central nervous system (CNS) metastasis.
Patients with a history of treated brain metastases are eligible provided that disease is stable following treatment for at least 8 weeks prior to randomization and no requirement for corticosteroid use
Poland
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Not yet recruiting
Wroclaw, Dolnośląskie, Poland, 53-413
Contact 48713689677
Principal Investigator: Lukasz Dolowy
Clinical Best Solutions - Recruiting
Lublin, Lubelskie, Poland, 20-078
Principal Investigator: Pawel Plaza
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie Not yet recruiting
Warszawa, Mazowieckie, Poland, 02-781
Principal Investigator: Pawel Wiechno
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego Not yet recruiting
Opole, Opolskie, Poland, 45-061
Contact 48774416088
Principal Investigator: Barbara Radecka
Szpitale Pomorskie Sp. z o. o. Not yet recruiting
Gdynia, Pomorskie, Poland, 81-519
Contact 48587260417
Principal Investigator: Dorota Filarska
Wielkopolskie Centrum Onkologii Not yet recruiting
Poznan, Wielkopolskie, Poland, 61-866
Contact 486081222290
Principal Investigator: Jolanta Korczak
Salve Medica Not yet recruiting
Lodz, Łódzkie, Poland, 91-211
Principal Investigator: MONIKA KUKULSKA
Provita Profamilia - Recruiting
Piotrkow Trybunalski, Łódzkie, Poland, 97-300
Contact 4860185303
Principal Investigator: Jacek Fijuthhttps://clinicaltrials.gov/ct2/show/NCT ... w=2&rank=8