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RECRUITING
NCT06244004
PHASE2

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

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2024-02-18

Completion Date

2028-02-18

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Antiandrogen Therapy

Undergo SOC ADT

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cytotoxic Chemotherapy

Receive SOC cytotoxic chemotherapy

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET

RADIATION

Radiation 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