RecruitingPhase 2NCT06244004

FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial

A Randomized Open Label Phase II Trial of FDG-PET-Guided Metastasis Directed Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer: PRTY Trial: PET- Guided Radiotherapy Consolidation


Sponsor

Northwestern University

Enrollment

125 participants

Start Date

Feb 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread from where it first started (primary site) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer death among men in the United States, despite the approval of several life-prolonging treatments by the Food and Drug Administration. However, over the past 10 years, there have been significant improvements in prolonging the lives of those with metastatic hormone sensitive prostate cancer, specifically by adding treatments to standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors) to delay the progression of cancer and prolong life for patients with metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that remain active despite standard treatment. Giving MDRT plus standard treatment to patients with FDG-PET-identified cancer sites may work better than standard treatment alone in treating metastatic hormone sensitive prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called the PRTY Trial) is studying whether using advanced PET scan imaging to find cancer spots can guide targeted radiation therapy to those specific sites in men with metastatic prostate cancer — cancer that has spread beyond the prostate — who are also receiving hormone therapy. The goal is to see if wiping out visible tumor spots can improve outcomes. **You may be eligible if...** - You are 18 or older - You have prostate cancer that has spread to other parts of the body (metastatic) - You are receiving or planning to receive hormone therapy (androgen deprivation therapy) - You are willing to undergo a PSMA PET scan (an advanced imaging test for prostate cancer) - Your general health allows for radiation treatment **You may NOT be eligible if...** - You have prostate cancer that has already progressed to castration-resistant disease with widespread bone or organ involvement beyond what can be targeted - You have serious medical conditions that would prevent you from receiving radiation - You have had prior pelvic radiation that would prevent safe additional treatment - You have very poor general health (ECOG status 4) 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.

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Interventions

DRUGAntiandrogen Therapy

Undergo SOC ADT

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo CT

DRUGCytotoxic Chemotherapy

Receive SOC cytotoxic chemotherapy

PROCEDUREFDG-Positron Emission Tomography

Undergo FDG-PET

RADIATIONRadiation Therapy

Undergo MDRT


Locations(6)

Northwestern University

Chicago, Illinois, United States

Northwestern Medicine: Kishwaukee

DeKalb, Illinois, United States

Northwestern Medicine: Delnor

Geneva, Illinois, United States

Northwestern University Oak Brook IL453

Oak Brook, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Northwestern Medicine: Warrenville

Warrenville, Illinois, United States

View Full Details on ClinicalTrials.gov

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NCT06244004


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