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OncoMatch/Clinical Trials/NCT06244004

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

Is NCT06244004 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Antiandrogen Therapy and Cytotoxic Chemotherapy for castration-sensitive prostate carcinoma.

Phase 2RecruitingNorthwestern UniversityNCT06244004Data as of May 2026

Treatment: Antiandrogen Therapy · Cytotoxic ChemotherapyThis 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Required: Stage IVB

Metastatic disease required

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

Must have received: androgen deprivation therapy (leuprolide, goserelin, degarelix, relugolix, surgical castration)

Patients must have mHSPC and be planning therapy with cytotoxic therapy, with or without an androgen receptor (AR) pathway inhibitor (ARPI), to be eligible for Cohort 1. ... Patients must have mHSPC and be planning therapy with androgen deprivation therapy (ADT), with or without an ARPI, and not planning cytotoxic therapy, to be eligible for Cohort 2.

Cannot have received: androgen deprivation therapy (leuprolide, goserelin, degarelix, relugolix, surgical castration)

Exception: current 'on' period started within one year of enrollment

Patients who started androgen deprivation therapy (ADT) more than 26 weeks +/- 26 weeks (1 year) prior to enrollment.

Cannot have received: androgen receptor pathway inhibitor

Patients who started intensification of therapy beyond ADT (e.g., AR pathway inhibitor, cytotoxic therapy) more than 26 weeks +/- 4 weeks (30 weeks) prior to registration.

Cannot have received: cytotoxic chemotherapy (docetaxel, cabazitaxel)

Patients who started intensification of therapy beyond ADT (e.g., AR pathway inhibitor, cytotoxic therapy) more than 26 weeks +/- 4 weeks (30 weeks) prior to registration.

Lab requirements

Blood counts

Leukocytes (WBC) ≥ 2,500/mcL (growth factor use allowed); Absolute neutrophil count (ANC) ≥ 1,500/mcL (growth factor use allowed); Platelets (PLT) ≥ 80,000/mcL (transfusions allowed)

Leukocytes (WBC) ≥ 2,500/mcL (growth factor use allowed) (obtained prior to registration). Absolute neutrophil count (ANC) ≥ 1,500/mcL (growth factor use allowed) (obtained prior to registration). Platelets (PLT) ≥ 80,000/mcL (transfusions allowed) (obtained prior to registration).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Northwestern University · Chicago, Illinois
  • Northwestern Medicine: Kishwaukee · DeKalb, Illinois
  • Northwestern Medicine: Delnor · Geneva, Illinois
  • Northwestern University Oak Brook IL453 · Oak Brook, Illinois
  • Northwestern Medicine Orland Park · Orland Park, Illinois

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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