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

NCT06479187 | Active Not Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 24-717
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Metastatic Prostate Cancer; Hormone Sensitive Prostate Cancer; Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Keywords

PSMA; PET; Metastatic Hormone-sensitive Prostate Cancer (mHSPC); prostate cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with residual PSMA-avid disease on 18F-rhPSMA7.3 PSMA PET after 6 months of treatment for metastatic hormone sensitive prostate cancer

  metric use is percent of men with residual PSMA avid disease compared to all men undergoing the scan.

  At the time of the 18F-rhPSMA-7.3 PSMA-PET/CT scan done 6 months after starting therapy for metastatic hormone sensitive prostate cancer

Study Arms (1)

PSMA-PET/CT arm

EXPERIMENTAL

Patients will undergo 18F-rhPSMA-7.3 PSMA PET/CT scan before and after 6 months of treatment for metastatic hormone sensitive prostate cancer. Patients will undergo chart review every 3 months for 1 year after the second 18F-rhPSMA-7.3 PSMA PET/CT scan.

Drug: 18F-rhPSMA-7.3; Device: PET/CT

Interventions

18F-rhPSMA-7.3 DRUG

radiopharmaceutical targeting PSMA and used to image prostate cancer with PET scan.

PSMA-PET/CT arm

PET/CT DEVICE

Diagnostic imaging test

PSMA-PET/CT arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Not based on self-representation of gender identity as biologic females are not eligible as they do not develop prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Blue Earth Diagnostics: collaborator

Study Sites (2)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Heather Jacene, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Nuclear Medicine and Molecular Imaging

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)