RecruitingPhase 2NCT06369610

Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer

Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging


Sponsor

Mayo Clinic

Enrollment

110 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a personalized, risk-based approach to hormone therapy duration combined with radiation can be used safely for men with high-risk prostate cancer, with the goal of reducing hormone therapy side effects for lower-risk patients while maintaining effectiveness. **You may be eligible if...** - You have a confirmed diagnosis of high-risk prostate cancer - Your cancer has one or more high-risk features: Gleason score 8–10, T3–T4 staging, or PSA ≥ 20 - Your cancer is staged as T1c–T4 with no or limited lymph node spread - You have an ECOG performance status of 0–2 (able to carry out most daily activities) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You have received prior radiation therapy to the pelvis - You have significant other medical conditions that make hormone therapy or radiation unsafe - You are unwilling to sign institutional review board consent 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

DRUGAbiraterone Acetate

Given abiraterone acetate

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

BIOLOGICALGonadotropin-releasing Hormone Analog

Given SC or IM

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONRadiation Therapy

Undergo radiation therapy


Locations(1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

View Full Details on ClinicalTrials.gov

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

Visit

NCT06369610


Related Trials