PEMBROLIZUMAB for Recurrent prostate cancer

Inclusion criteria

• {"criterion_text":"- 1. Male patients who are at least 18 years of age on the day of signing informed consent."}
• {"criterion_text":"- 2. Histologically confirmed diagnosis of an adenocarcinoma of the prostate and a BCR or PSA persistence after RP."}
• {"criterion_text":"- 3. 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)."}
• {"criterion_text":"- 4. Imaging within 50 days prior to study inclusion (patient registration) is mandatory ([68Ga] or [18F] PSMA PET-CT as standard imaging modality, alternatively CT abdomen and full-body bone scan)."}
• {"criterion_text":"- 5. PSA value between ≥0.2 and ≤1.0 ng/ml measured at least six weeks postoperatively."}
• {"criterion_text":"- 6. 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.)"}
• {"criterion_text":"- 7. Written informed consent obtained according to international guidelines and local law."}
• {"criterion_text":"- 8. Patients further having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1."}
• {"criterion_text":"- 9. Patients with adequate organ function as defined in Table 2."}

Exclusion criteria

• {"criterion_text":"- 1. Prior-therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)."}
• {"criterion_text":"- 10. Known active CNS metastases and/or carcinomatous meningitis."}
• {"criterion_text":"- 11. Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients."}
• {"criterion_text":"- 12. Active autoimmune disease that required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed."}
• {"criterion_text":"- 13. History of (non-infectious) pneumonitis/intestinal lung disease that required steroids or currently pneumonitis/intestinal lung disease."}
• {"criterion_text":"- 14. Active infection requiring systemic therapy."}
• {"criterion_text":"- 15. History of Human Immunodeficiency Virus (HIV) infection."}
• {"criterion_text":"- 16. History of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. No testing is required."}
• {"criterion_text":"- 17. History of active TB (Bacillus Tuberculosis)."}
• {"criterion_text":"- 18. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator."}
• {"criterion_text":"- 19. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial."}
• {"criterion_text":"- 2. Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to registration (like neo-adjuvant androgen deprivation therapy (ADT), secondary hormone ablation or taxanbased chemotherapy)."}
• {"criterion_text":"- 20. History of allogeneic tissue/solid organ transplantation."}
• {"criterion_text":"- 3. Prior radiotherapy within 4 weeks before start of study medication. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis."}
• {"criterion_text":"- 4. Distant metastases or suspicious lymph nodes outside the lower pelvis in imaging with PSMA PET-CT (patients with PET positive bone lesions that are morphologically not clearly suspicious of metastases and would not change clinical practice can be included)."}
• {"criterion_text":"- 5. Adverse histology of RP specimen (e.g. neuroendocrine or small cell)"}
• {"criterion_text":"- 6. Any vaccination with live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study medication. Administration of killed vaccine is allowed."}
• {"criterion_text":"- 7. Currently or previously participating in a study of an investigational product within 4 weeks prior to the first dose of study medication."}
• {"criterion_text":"- 8. Diagnosis of immunodeficiency, chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication."}
• {"criterion_text":"- 9. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years."}

Primary endpoints

• {"endpoint_text":"- complete biochemical response defined as a PSA level below limit of detection at week 60 after start of pembrolizumab.","definition_or_measurement_approach":"Complete biochemical response defined as PSA level below the limit of detection measured at week 60 after start of pembrolizumab."}

Secondary endpoints

• {"endpoint_text":"- radiographic progression-free survival (rPFS) at week 60 after start of pembrolizumab.","definition_or_measurement_approach":"Radiographic progression-free survival assessed at week 60 after start of pembrolizumab (imaging-based progression assessment, per protocol)."}
• {"endpoint_text":"- PSA-nadir level and time to PSA-nadir (TTN)","definition_or_measurement_approach":"PSA nadir level and time from treatment start to PSA nadir (TTN) measured from serial PSA assessments."}
• {"endpoint_text":"- Pembrolizumab exposure: number of administered pembrolizumab doses","definition_or_measurement_approach":"Count of administered pembrolizumab doses per participant."}
• {"endpoint_text":"- ADT: administered concomitant substances, duration, dosage (in high-risk patients only)","definition_or_measurement_approach":"Documentation of concomitant androgen deprivation therapy (ADT): substances given, duration and dosage (only in high-risk patients)."}
• {"endpoint_text":"- Time to initiation of subsequent therapy (secondary ADT or novel hormonal agents [NHA])","definition_or_measurement_approach":"Time from study treatment start to initiation of subsequent therapy (secondary ADT or novel hormonal agents), measured in days/weeks as per protocol."}
• {"endpoint_text":"- Functional assessment of cancer therapy - Prostate: FACT-P ver. 4.0 (www.facit.org)","definition_or_measurement_approach":"Health-related quality of life measured using the FACT-P version 4.0 instrument."}

Germany

Earliest CTIS Part Ii Submission Date

11-04-2024

Latest Decision Or Authorization Date

05-02-2025

Processing Time Days

300

Number Of Sites

1

Number Of Participants

49

Primary sponsor

Full Name

Medical Center - University Of Freiburg

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"MSD SHARP & DOME GmbH","duties_or_roles":"Source of monetary support","organisation_type":""}