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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 Bridget Koontz

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

TALON Trial 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.Check my eligibility

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.See study design

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.

TALON Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

12 week post-operative PSA

Pathologic response in prostatectomy tissue

TALON 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

Pembrolizumab

FDA approved

Stereotactic body radiation therapy

2017

Completed Phase 1

~30

Radical Prostatectomy

2005

Completed Phase 2

~4550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bridget KoontzLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,935 Total Patients Enrolled

26 Trials studying Prostate Cancer

16,958 Patients Enrolled for Prostate Cancer

Daniel George, MDLead Sponsor

7 Previous Clinical Trials

215 Total Patients Enrolled

3 Trials studying Prostate Cancer

138 Patients Enrolled for Prostate Cancer

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04569461 — Phase 2

Prostate Cancer Research Study Groups: Single Arm

Prostate Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04569461 — Phase 2

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04569461 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned pembrolizumab for medical use?

"The safety of pembrolizumab received a score of 2 since Phase 2 trials have generated data that supports its safety, but no evidence to support efficacy."

Answered by AI

Can you tell me the size of the population under examination in this research endeavor?

"Unfortunately, this clinical trial is not currently accepting any more applicants. Initially posted on the 1st of April 2023 and last edited on 16th August 2022; if you are seeking other studies, there are 1321 trials searching for prostate cancer patients and 961 looking to recruit people that have been administered pembrolizumab."

Answered by AI

To what types of diseases is pembrolizumab typically prescribed?

"Pembrolizumab is widely accepted as the best method for treating malignant neoplasms. It has also proven to be effective in managing disease progression after chemotherapy, microsatellite instability high, and unresectable melanoma cases."

Answered by AI

Are applications for this trial being accepted presently?

"Clinicaltrials.gov reveals that this research study is no longer recruiting patients, with original posting on April 1st 2023 and final update taking place in August 16th 2022. Despite the current inactive status of this trial, there are 2282 other medical studies currently enrolling individuals into their respective experiments."

Answered by AI

Has pembrolizumab been subject to further scientific inquiry?

"Currently, 961 clinical studies are ongoing concerning the efficacy of pembrolizumab with 122 already in Phase 3. There is a concentration of research for this medication in Houston, Texas but overall there are 35 731 sites around the world conducting trials on its use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Daniel George, MD 2024. "Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04569461.

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