Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.

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. Written informed consent. Each patient must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures, required for the study, and is willing to participate in the study. 2. Patient must be a man ≥18 years of age. 3. Histologically or cytologically confirmed adenocarcinoma of prostate. 4. Metastatic hormone-sensitive prostate cancer. 5. PSA \>5 ng/ml at diagnosis of metastatic disease. 6. Patients eligible to continue treatment with apalutamide and ADT and without contra-indication to receive docetaxel. 7. Patients with at least 24 weeks and no more than 30 weeks of apalutamide. 8. Patients with a maximum of 12 weeks ADT before apalutamide initiation. 9. Lack of achievement of deep PSA response after 24 weeks and no more than 30 weeks of apalutamide. Deep PSA response is defined as PSA ≤ 0.2 ng/ml or PSA response ≥ 90% in combination with a PSA ≤4 ng/ml. Therefore, a non-deep PSA response is defined as PSA \> 0.2 ng/ml in c…

✦ Analyst Commentary

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

Source