Radiotherapy in Combination With Pembrolizumab in Patients With PSA Persistence or Biochemical Recurrence After Radical Prostatectomy Due to Prostate Cancer
To evaluate the efficacy and safety of a pembrolizumab therapy of pembrolizumab in combination with standard salvage radiation therapy (SRT) in patients with biochemical recurrence (BCR) of prostate-specific antigen (PSA) persistence after radical prostatectomy (RP).
• Male patients who are at least 18 years of age on the day of signing informed consent
• Histologically confirmed diagnosis of an adenocarcinoma of the prostate and a BCR or PSA persistence after RP
• Histology of the RP specimen needs to fulfill the following criteria: adenocarcinoma of the prostate, Gleason score 7-10; pNX or pN0 or pN1 (max. 2 lymph nodes involved)
• Imaging within 50 days prior to study inclusion is mandatory (patient registration) (\[68Ga\] or \[18F\] PSMA PET-CT as standard imaging modality, alternatively CT abdomen and full-body bone scan)
• PSA value between ≥0.2 and ≤1.0 ng/ml measured at least six weeks postoperatively
• The patients agree not to undergo testicular sperm extraction for at least 90 days after the last administration of pembrolizumab. (Due to prior surgical removal of the prostate no contraception is necessary.)
• Written informed consent obtained according to international guidelines and local law
• Patients further having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Patients with adequate organ function as defined in clinical trial protocol (CTP) (Section 4)