RecruitingPhase 2NCT04931979

SRT in Combination With Pembrolizumab in Patients With Recurrent Prostate Cancer After Radical Prostatectomy

Radiotherapy in Combination With Pembrolizumab in Patients With PSA Persistence or Biochemical Recurrence After Radical Prostatectomy Due to Prostate Cancer


Sponsor

Prof. Dr. med. Christian Gratzke

Enrollment

49 participants

Start Date

Oct 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining targeted radiation (called salvage radiotherapy) with the immunotherapy drug pembrolizumab improves outcomes for men with prostate cancer that has come back after their prostate was surgically removed. **You may be eligible if...** - You are a male patient, 18 or older - You previously had your prostate surgically removed and your PSA (a blood marker for prostate cancer) has risen again (between 0.2 and 1.0 ng/ml) - Your original prostate cancer was a Gleason score of 7–10 (moderate to aggressive) - You have had recent imaging within the last 50 days **You may NOT be eligible if...** - You still have an undetectable PSA after surgery - Your PSA is higher than 1.0 ng/ml at enrollment - You have plans to father children in the near term (treatment may affect fertility temporarily) - You have certain serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab Injection [Keytruda]

Up to 17 cycles of pembrolizumab until disease progression, toxicity, death, or withdrawal of IC (whichever occurs first)

RADIATIONSalvage Radiation Therapy (SRT)

SRT according to standard of care (SRT with at least 66 Gy)


Locations(1)

Clinic of Urology, Medical Center - University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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NCT04931979


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