NCT04569461

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll prostate cancer patients with an unfavorable intermediate- or high-risk diagnosis. The purpose of this study is to determine whether a regimen of pembrolizumab and low dose prostate radiation or low dose prostate radiation alone prior to a prostatectomy affects cells of the immune system and if it is a safe option for this stage of prostate cancer. Participants will be randomized 1:1 (like flipping a coin) to receive pembrolizumab, low dose prostate radiation and a prostatectomy or low dose prostate radiation and a prostatectomy. Pembrolizumab is an investigational drug that increases the ability of the immune system to kill tumor cells. Low dose radiation can alter the way tumor cells look to the immune cells. For example, the immune cells may express different proteins that make them more susceptible to immune cell killing or the structure of the tumor may be altered to allow the immune cells to infiltrate the tumor more thoroughly. The prostate tissue collected from the prostatectomy will be analyzed for differences in pathology and local immune cell infiltration, and participants will be followed for 2 years to watch for prostate specific antigen (PSA) recurrence and prostate cancer recurrence.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-09-29
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study