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New treatment option for Castration-Sensitive Prostate Carcinoma
Official title FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial
ClinicalTrials.gov ID: NCT06244004
What this study is testing
What is Antiandrogen Therapy?
Antiandrogen Therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for castration-sensitive prostate carcinoma.
Also referred to as ADT, Androgen Deprivation Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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...
- 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:
You likely can't join if
- Patients with prostate cancer that is castration resistant, which is defined as two consecutive rising PSA values despite testosterone level \< 50...
- 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)...
- 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...
- Patients who started intensification of therapy beyond ADT (e.g., AR pathway inhibitor, cytotoxic therapy) more than 26 weeks +/- 4 weeks (30 weeks)...
- Note: First generation antiandrogens (bicalutamide) are not considered intensification of therapy beyond ADT.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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.
- people 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...
- Patients who are enrolled in another therapeutic clinical trial that would preclude them from participating in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- DeKalb, Illinois, United States
- Geneva, Illinois, United States
- Oak Brook, Illinois, United States
- Orland Park, Illinois, United States
- Warrenville, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; DeKalb, Illinois, United States; Geneva, Illinois, United States; Oak Brook, Illinois, United States; Orland Park, Illinois, United States; Warrenville, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.