Trimodality Therapy for Prostate Cancer
(TALON Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBridget Koontz, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Duke University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Men aged 18+ with intermediate/high-risk prostate cancer who can sign consent, have adequate organ function, and meet specific risk criteria (e.g., Gleason score, PSA levels) as per NCCN guidelines. Excluded are those with metastasis, prior pelvic treatments like radiation or cryotherapy, recent investigational drug use, active autoimmune diseases requiring systemic treatment within the past 2 years, chronic steroid/immunosuppressive drug use (with some exceptions), uncontrolled illnesses that could affect study compliance or safety.

Inclusion Criteria

I am fully active and can carry on all pre-disease activities without restriction.

I am willing and able to follow the study's treatment plan and attend all visits.

My organs and bone marrow are functioning well.

+5 more

Exclusion Criteria

I have had or currently have lung inflammation treated with steroids.

My cancer has spread to my bones, brain, organs, or soft tissues.

I have had radiation, cryotherapy, or HIFU treatments in the pelvic area.

+14 more

Participant Groups

The TALON trial is testing a 'trimodal therapy' for prostate cancer involving pembrolizumab (an immunotherapy drug), SBRT to the prostate gland, and short-term ADT followed by radical surgery to remove the prostate. The goal is to see if this combination delays the rise of PSA compared to historical data over a follow-up period of two years.

2Treatment groups

Experimental Treatment

Group I: Arm B: Low dose prostate radiation and prostatectomyExperimental Treatment2 Interventions

Participants in Arm B will receive: * Low dose prostate radiation of one dose of 2 Gy to the prostate and seminal vesicles * Prostatectomy as part of the routine care for their cancer

Group II: Arm A: pembrolizumab, low dose prostate radiation and prostatectomyExperimental Treatment3 Interventions

Participants in Arm A will receive: * Pembrolizumab 400 mg intravenously every 6 weeks for 9 cycles. * Low dose prostate radiation of one dose of 2 Gy to the prostate and seminal vesicles * Prostatectomy as part of the routine care for their cancer

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: