Actively Recruiting
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial
Led by Northwestern University · Updated on 2026-03-30
125
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have metastatic prostate cancer confirmed by conventional imaging (CT, MRI, or bone scan).
- Patients aged 18 years or older at consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
- Cohort 1: Patients with metastatic hormone sensitive prostate cancer (mHSPC) planning or receiving cytotoxic therapy (e.g., docetaxel) with or without androgen receptor pathway inhibitor, within 30 weeks of starting cytotoxic therapy and within one year of starting ADT.
- Cohort 2: Patients with mHSPC planning or receiving ADT without cytotoxic therapy, within 30 weeks of starting androgen receptor pathway inhibitor and within one year of starting ADT.
- White blood cell count (WBC) ≥ 2,500/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, and platelets (PLT) ≥ 80,000/mcL before registration.
- Ability to lie flat and remain still for 15-20 minutes and tolerate FDG-PET/CT imaging and radiation therapy.
- Patients with prior or concurrent malignancies not interfering with study endpoints or standard prostate cancer therapy.
- Life expectancy of at least 6 months as judged by the investigator.
- Ability and willingness to provide informed consent or have a legally authorized representative consent if the patient has impaired decision-making capacity.
You will not qualify if you...
- Patients with castration-resistant prostate cancer defined by two rising PSA values despite testosterone < 50 ng/dL.
- Patients who started ADT more than one year prior to enrollment.
- Patients who started therapy intensification beyond ADT (e.g., androgen receptor pathway inhibitor or cytotoxic therapy) more than 30 weeks prior to registration.
- Known allergy to contrast agents or contraindication to FDG-PET that cannot be managed safely.
- Enrollment in another therapeutic clinical trial that conflicts with participation in this trial.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Northwestern Medicine: Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
3
Northwestern Medicine: Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
4
Northwestern University Oak Brook IL453
Oak Brook, Illinois, United States, 60523
Actively Recruiting
5
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Not Yet Recruiting
6
Northwestern Medicine: Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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