Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: 1. Patients must have signed a written informed consent form prior to any trial specific procedures 2. Age ≥18 years old and ≤80 years old 3. Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with radical prostatectomy 4. Tumor stage pT2, pT3 or pT4\* (\*only in case of bladder neck involvement) 5. Patients should have no clinical and radiological signs (18FCH-PET CT-scan or 68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse or pelvic nodal relapse (N1) detected on PET CT-scan can be randomized 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 7. PSA ≥0.2 ng/mL at the time of randomization with an elevation of PSA over three consecutive assays. PSA increases over a 1-month interval minimum 8. At least 3 months between radical prostatectomy and randomization. 9. High-risk features as defined by at least one of these characteristics: PSA at relapse \>0.5 ng/mL or Gleason score \>7 or tumor stage …

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Source