Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON)

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 30, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

Conditions
Prostate Cancer
Interventions
DRUG

pembrolizumab

400 mg of pembrolizumab (KEYTRUDA) will be given by IV every 6 weeks for 9 cycles, for approximately one year of study drug administration.

RADIATION

Low dose prostate radiation

A single dose of 2 Gy of radiation will be given to the prostate and seminal vesicles on approximately Week 7 for Arm A and approximately 2 weeks prior to the prostatectomy for Arm B.

PROCEDURE

Radical Prostatectomy

Robotic assisted laparoscopic prostatectomy (RALP) surgery will be performed at approximately Week 9 for Arm A and approximately 2 weeks after the low dose prostate radiation for Arm B. This surgery is part of the participants routine medical care.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Duke University

OTHER

NCT04569461 - Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON) | Biotech Hunter | Biotech Hunter