The PRTY Trial: Radiation for Metastatic Prostate Cancer
This study, called The PRTY Trial, is looking at a new way to treat prostate cancer that has spread to other parts of the body (metastatic) and is sensitive to hormone therapy (castration-sensitive). It compares giving radiation therapy guided by FDG-PET scans (FDG-Positron Emission Tomography) along with standard treatments, versus standard treatments alone. Standard treatments include antiandrogen therapy and sometimes chemotherapy. The study aims to see if adding this radiation therapy improves how long people live without their cancer getting worse (progression-free survival) or if it leads to a complete response. You may be able to join if you are a man aged 18 or older with metastatic prostate cancer.
- Study design
- This is an interventional study planning to enroll 125 participants. It compares two groups: one receiving standard care plus radiation therapy, and another receiving standard care alone.
- What's involved
- You would undergo standard treatments like antiandrogen therapy and potentially chemotherapy. You would also have procedures like bone scans, CT scans, and FDG-PET scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be assessed for up to 36 months. Complete response rates will be measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06244004
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial
Recruiting
PHASE2Ages 18+InterventionalTreatmentNorthwestern UniversityInvestigator-initiated
~125 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Antiandrogen TherapyBone ScanComputed TomographyCytotoxic ChemotherapyFDG-Positron Emission TomographyRadiation Therapy
At a glance
Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) (Cohort 1)
Measured over From randomization to first radiographic or prostate-specific antigen (PSA)-based disease progression, or death, assessed up to 36 months
+1 more outcome measured
Conditions
Where it's being run
6 sites across 1 statesIllinois6
Study leadership
- David VanderWeele, MD, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Patients will continue their standard of care treatment while on study (plus MDRT if they are on Arm 2A). If they switch therapy because of progression, they will be considered to have progressed.
Patients can be enrolled anytime within the initial \~6 month standard of care time period, though early enrollment is preferred. Screening can take place prior to starting standard of care (SOC) therapy or during standard of care therapy, as long as they are within 30 weeks of starting therapy.
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).
Patient must be able to lie flat and still for approximately 15-20 minutes AND able to tolerate FDG-PET/CT radiographical imaging and radiation treatment planning and delivery.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the endpoints for this study, in the opinion of the treating investigator, are eligible.
Note; Patients are ineligible if another known malignancy makes it difficult to interpret if FDG-avid lesions represent prostate cancer, or if the malignancy is expected to interfere with patients receiving standard therapy for prostate cancer for 2 years from study enrollment.
Patients must have a life expectancy of at least 6 months, in the opinion of the treating investigator.
Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration.
Note: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
Exclusion
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.
What this trial measures
- Progression free survival (PFS) (Cohort 1)From randomization to first radiographic or prostate-specific antigen (PSA)-based disease progression, or death, assessed up to 36 months
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.
- Complete response rate (Cohort 2)At 6 months
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.