Who is eligible for clinical trial NCT06479187?

Participants must meet the protocol's inclusion criteria for Metastatic Prostate Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06479187 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-04

PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer (NCT06479187)

🔵 Active, Not Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Brigham and Women's Hospital

🩺 Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to learn if serial PSMA-PET/CT scans can be used to monitor response to therapy in metastatic hormone sensitive prostate cancer and can be potentially used to optimize future treatment approaches. The main questions it aims to answer are: What is the proportion of men with residual PSMA-avid disease on PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer? Do the findings on PSMA-PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer correlate with other markers of disease status, like PSA? Participants will: Receive standard of care treatment for metastatic hormone sensitive prostate cancer Undergo a PSMA-PET/CT scan before starting treatment Undergo a PSMA-PET/CT scan after 6 months of treatment Have a chart review every 3 months for 1 year after the 6 month PSMA-PET/CT scan

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (7 items).

Location: Dana Farber Cancer Institute — Boston, Massachusetts

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Participants must have histologically or cytologically confirmed prostate cancer, or unequivocal clinical evidence of mHSPC (eg. elevated PSA with lesions consistent with metastatic prostate cancer).
Age ≥18 years.
Participants must have mHSPC (either de novo or relapse after prior local therapy), as defined by extrapelvic nodal and/or visceral and/or bone lesions consistent with metastatic disease and seen on CT, bone scan and/or MRI. If participants have relapsed after prior local therapy, they must not have had systemic therapy in the past 6 months prior to study registration.
Serum testosterone \>150 ng/dL.
Planned initiation of systemic therapy with ADT (androgen deprivation therapy) and an AR pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) ± docetaxel. Initiation of systemic therapy up to 14 days prior to the baseline 18F-rhPSMA-7.3 PSMA-PET/CT is permitted.
Ability and willingness to comply with the study procedures.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial.
The effects of 18F-rhPSMA-7.3 on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after each 18F-rhPSMA-7.3 PSMA-PET scan.
Ability to understand and the willingness to sign a written informed consent document.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Systemic therapies other than ADT (GnRH/LHRH agonists or antagonists), AR pathways inhibitors (abiraterone, enzalutamide, apalutamide, darolutamide) and docetaxel are not permitted to be administered during the study period.
Radiation to the prostate and/or metastatic sites prior to the 6-month PET scan is not permitted.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Contraindications to PET/CT, including severe claustrophobia.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-rhPSMA-7.3.
Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Dana Farber Cancer Institute — Boston, Massachusetts
Dana-Farber Cancer Institute — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer — Toronto, Ontario

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗