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
4 other identifiers
interventional
125
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2024
Typical duration for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2024
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedStudy Start
First participant enrolled
February 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 18, 2028
March 30, 2026
March 1, 2026
3 years
January 29, 2024
March 27, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Progression free survival (PFS) (Cohort 1)
Will be estimated using the method of Kaplan-Meier and compared between treatment arms (Arms 1A and 1B) using the log-rank test. PFS rate at 18 months following randomization will be estimated and reported with the corresponding confidence intervals.
From randomization to first radiographic or prostate-specific antigen (PSA)-based disease progression, or death, assessed up to 36 months
Complete response rate (Cohort 2)
Will be estimated as the proportion of patients who demonstrate response based on fludeoxyglucose F-18-positron emission tomography (FDG-PET)-2 as compared to baseline (FDG-PET-1), and will be reported with the corresponding Clopper-Pearson confidence intervals. Response rates will be compared between Arms 2A and 2B using Fisher's exact test.
At 6 months
Secondary Outcomes (10)
Radiographic PFS (rPFS) (Cohort 1)
From randomization until disease progression on computed tomography (CT) and/or bone scan, or death from any cause, assessed up to 36 months
Proportions of patients with metastatic hormone sensitive prostate cancer (mHSPC) who achieve a serum PSA level < 0.4 ng/mL and < 0.01 ng/mL (Cohort 1)
Up to 36 months
Proportion of patients with Skeletal Related Events (SRE) (Cohort 1)
Up to 36 months
Incidence of adverse events (AEs) of metastasis directed radiation therapy (MDRT) (Cohort 1)
Up to 36 months
Objective response rate (Cohort 2)
Up to 36 months
- +5 more secondary outcomes
Study Arms (6)
Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)
EXPERIMENTALPatients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial.
Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)
ACTIVE COMPARATORPatients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.
Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)
ACTIVE COMPARATORPatients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients without PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.
Arm 2A (FDG-PET, MDRT, SOC ADT)
EXPERIMENTALPatients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
Arm 2B (FDG-PET, SOC ADT)
ACTIVE COMPARATORPatients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
Arm 2C (FDG-PET, SOC ADT)
ACTIVE COMPARATORPatients undergo an FDG-PET scan after 6 months of SOC ADT. Patients without PET-avid disease continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.
Interventions
Undergo bone scan
Undergo CT
Receive SOC cytotoxic chemotherapy
Undergo FDG-PET
Undergo MDRT
Undergo SOC ADT
Eligibility Criteria
You may qualify if:
- Patients must have metastatic prostate cancer on conventional imaging (CT scan, MRI, and/or bone scan).
- Note; Patients who had metastatic disease on conventional imaging prior to beginning ADT, but which has now resolved, are still eligible if they meet remaining eligibility criteria
- Patients must be ≥ 18 years of age at the time of informed consent.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Planned treatment requirements:
- Cohort 1
- 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 may also enroll if they are currently receiving or have completed cytotoxic therapy, if they are within 26 weeks +/- 4 weeks (30 weeks) of starting cytotoxic therapy and 26 weeks +/- 26 weeks (one year) of starting ADT.
- Note:
- Typically cytotoxic therapy means docetaxel. Patients planning other cytotoxic therapy (e.g. cabazitaxel) should discuss this with the study principal investigator (PI).
- If a patient registers as part of cohort 1 but ends up not receiving any cytotoxic therapy, the patient may be switched to cohort 2. This must be discussed with the study PI. If the patient received at least one cycle of cytotoxic therapy, they would remain in cohort 1.
- Patients will continue their standard of care treatment while on study (plus MDRT if they are on Arm 1A). Change in standard of care therapy will be allowed for toxicity or for de-escalation, and the patient will remain on study. Change in therapy for progression is considered a progression event.
- Cohort 2
- 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. Patients may also enroll if they are within 26 weeks +/- 4 weeks (30 weeks) of starting an AR pathway inhibitor and 26 weeks +/- 26 weeks (one year) of starting ADT.
- Note:
- If patients register as part of cohort 2 but end up receiving one or more cycles of cytotoxic therapy, they may be switched to cohort 1. This must be discussed with the study PI.
- +11 more criteria
You may not qualify if:
- Patients with prostate cancer that is castration resistant, which is defined as two consecutive rising PSA values despite testosterone level \< 50 ng/dL.
- Patients who started androgen deprivation therapy (ADT) more than 26 weeks +/- 26 weeks (1 year) prior to enrollment.
- Note: ADT is defined as luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix, relugolix) or surgical castration. Bicalutamide 50 mg daily does not count as ADT.
- Note: Patients will not be excluded if they were previously on intermittent therapy, as long as the current "on" period started within one year of enrollment.
- 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.
- Note: First generation antiandrogens (bicalutamide) are not considered intensification of therapy beyond ADT.
- Subjects with a known allergy to contrast material and/or contraindication to FDG-PET
- Note: Contrast allergies: Patients with a known allergy to imaging contrast agent(s) are eligible, provided prior reactions have not been severe, and the patient is willing and able to receive pre-medications and/or supportive care according to institutional standard practice (e.g., corticosteroids, antihistamines, etc.) to manage reactions adequately.
- Patients who are enrolled in another therapeutic clinical trial that would preclude them from participating in this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- Northwestern Universitylead
Study Sites (6)
Northwestern University
Chicago, Illinois, 60611, United States
Northwestern Medicine: Kishwaukee
DeKalb, Illinois, 60115, United States
Northwestern Medicine: Delnor
Geneva, Illinois, 60134, United States
Northwestern University Oak Brook IL453
Oak Brook, Illinois, 60523, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
Northwestern Medicine: Warrenville
Warrenville, Illinois, 60555, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David VanderWeele, MD, PhD
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2024
First Posted
February 6, 2024
Study Start
February 18, 2024
Primary Completion (Estimated)
February 18, 2027
Study Completion (Estimated)
February 18, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03