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Monoclonal Antibodies

Trimodality Therapy for Prostate Cancer (TALON Trial)

Phase 2

Waitlist Available

Led By Bridget Koontz, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after prostatectomy

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will enroll prostate cancer patients who have an unfavorable outlook. They will receive a combination of drugs, radiation, and androgen deprivation therapy. Afterward, they will have surgery to remove the prostate. The tissue will be analyzed and they will be monitored for 2 years to see if their cancer returns.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs due to pembrolizumab; skin irritation and fatigue from radiation therapy; hot flashes and sexual dysfunction from ADT; surgical risks such as bleeding or infection from radical prostatectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after prostatectomy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after prostatectomy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after prostatectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of subjects who achieve biochemical progression-free survival (BPFS) at 24 months (2 years)

Secondary study objectives

12 week post-operative PSA

Pathologic response in prostatectomy tissue

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment4 Interventions

Subjects with unfavorable localized prostate cancer will be enrolled.This is a single arm, phase II study of pembrolizumab (Keytruda), SBRT, and Short-term Androgen Deprivation Therapy (STADT), known together as trimodality therapy, followed by radical prostatectomy 8 weeks after SBRT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic body radiation therapy

2017

Completed Phase 1

~30

Pembrolizumab

FDA approved

Radical Prostatectomy

2005