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

NCT04931979 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-03-01

No results posted yet for this study

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).

Conditions

  • Urologic Cancer
  • Biochemical Recurrence of Malignant Neoplasm of Prostate

Interventions

DRUG

Pembrolizumab Injection [Keytruda]

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

RADIATION

Salvage Radiation Therapy (SRT)

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

Sponsors & Collaborators

Principal Investigators

  • Christian Gratzke, Prof. Dr. · University Medical Center - University of Freiburg, Clinical of Urology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2025-07-01
Completion
2026-04-01

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04931979 on ClinicalTrials.gov