Actively Recruiting
FDG-PET-Guided Metastasis Directed Radiation Therapy for Metastatic Hormone Sensitive Prostate Cancer: The PRTY Phase II Randomized Trial
Led by Northwestern University · Updated on 2026-03-30
125
Participants Needed
6
Research Sites
52 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
Researchers are evaluating the use of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) combined with standard treatments compared to standard treatments alone for men with metastatic hormone sensitive prostate cancer. This phase II trial focuses on patients whose prostate cancer has spread beyond the original site and remains sensitive to androgen deprivation therapy (ADT). The study aims to see if this combined approach can improve progression-free survival and the complete response rate in different patient groups based on their treatment status. Participants are divided into two cohorts: Cohort 1 includes patients undergoing cytotoxic chemotherapy plus ADT, while Cohort 2 includes those receiving ADT without cytotoxic chemotherapy. After six months of standard care, patients receive an FDG-PET scan to detect active cancer sites. Those with PET-avid disease are randomized to receive either MDRT plus standard care or standard care alone, with MDRT targeting up to 5 disease sites if no unacceptable toxicity occurs. Patients without PET-avid disease continue standard care. Throughout the trial, participants undergo CT scans, bone scans, and additional FDG-PET scans as applicable. Participants will be monitored regularly with imaging and lab tests, including prostate-specific antigen (PSA) levels, to measure cancer progression and response. Follow-up visits occur at 3 and 6 months after treatment completion, then every 6 months up to 36 months. Researchers evaluate progression-free survival, radiographic progression, PSA levels, skeletal events, response rates on imaging, and safety of MDRT. The study lasts up to three years, allowing detailed assessment of treatment effects and side effects over time.
CONDITIONS
Brief 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...
- Male patients aged 18 years or older
- Diagnosed with metastatic prostate cancer confirmed by conventional imaging (CT, MRI, or bone scan)
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3
- Planning or currently receiving cytotoxic chemotherapy plus androgen deprivation therapy (ADT) for Cohort 1, or planning or currently receiving ADT without cytotoxic chemotherapy for Cohort 2
- Blood counts: leukocytes (WBC) ≥ 2,500/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, platelets (PLT) ≥ 80,000/mcL
- Ability to lie flat and tolerate FDG-PET/CT imaging and radiation therapy planning and delivery
- Life expectancy of at least 6 months
- Ability to understand and willing to sign informed consent (patients with impaired decision-making capacity may participate with a legally authorized representative)
You will not qualify if you...
- Castration-resistant prostate cancer, defined as two rising PSA values despite testosterone < 50 ng/dL
- Started androgen deprivation therapy (ADT) more than 26 weeks ± 26 weeks (1 year) before enrollment
- Started therapy intensification beyond ADT (such as AR pathway inhibitors or cytotoxic therapy) more than 26 weeks ± 4 weeks (30 weeks) before registration
- Known severe allergy or contraindication to FDG-PET contrast materials (unless manageable with pre-medication)
- Enrollment in another therapeutic clinical trial that prevents participation in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At 6 months after starting SOC therapy
Participants undergo an FDG-PET scan after 6 months of standard of care (SOC) therapy to determine cohort and treatment assignment based on PET-avid disease status.
1 visit (in-person)
Duration - Variable duration during active treatment phase following randomization
Participants continue SOC therapy and, if assigned to experimental arms, undergo metastasis-directed radiation therapy (MDRT) to up to 5 disease sites in the absence of unacceptable toxicity. Participants also undergo CT and bone scans throughout the treatment period.
Visits for radiation therapy and imaging as scheduled throughout treatment
Duration - 6 months after randomization
Participants in Cohort 2 undergo an additional FDG-PET scan at 6 months post-randomization to assess treatment response.
1 visit (in-person)
Duration - Up to 36 months after treatment completion
After completion of study treatment, participants are followed up with visits at 3 months (for Arms 1A, 1B, 2A, 2B), 6 months, and then every 6 months until 36 months to monitor disease progression, safety, and outcomes.
Visits at 3 months (selected arms), 6 months, then every 6 months up to 36 months
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
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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