RecruitingPhase 1Phase 2NCT07182279

Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer

High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)


Sponsor

The Methodist Hospital Research Institute

Enrollment

29 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I/II trial evaluating the effectiveness of adding neoadjuvant HDR-B prior to RALP for HR-PCa patients with selective AAB for decipher high risk or pathologically node positive patients. Patients with newly diagnosed, histologically confirmed, non-metastatic, HR-PCa who are scheduled to receive RALP will be eligible to participate in the study.


Eligibility

Sex: MALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving high-dose rate brachytherapy (internal radiation delivered directly to the prostate using small seeds) before surgical prostate removal can improve outcomes in men with high-risk prostate cancer. It combines two treatment approaches that are each effective alone. **You may be eligible if...** - You are 40 or older - You have been diagnosed with prostate cancer confirmed by biopsy - Your cancer is considered high-risk based on PSA levels, Gleason score (a measure of cancer aggressiveness), or the size/stage of the tumor - Your cancer has not spread to bones or lymph nodes (confirmed by scan) - You are in good enough health to undergo both the radiation and surgery procedures **You may NOT be eligible if...** - Your cancer has spread beyond the prostate to lymph nodes or other organs - You have previously received hormone therapy, radiation, or surgery for prostate cancer - You are not medically fit for surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBrachytherapy

All patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with high genomic risk or node positivity will receive short course adjuvant AAB.


Locations(1)

Houston Methodist

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07182279


Related Trials