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Active, not recruitingNCT06479187Updated Nov 5, 2025

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

A Phase 4 interventional study of 18F-rhPSMA-7.3 and PET/CT in Metastatic Prostate Cancer, Hormone Sensitive Prostate Cancer and Metastatic Hormone-sensitive Prostate Cancer (mHSPC), sponsored by Brigham and Women's Hospital. Active, not recruiting at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-05.

Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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

Read the detailed description

The current approach to imaging metastatic hormone sensitive prostate cancer (mHSPC) is via conventional scans (CT/MRI/bone scan), but prostate specific membrane antigen (PSMA)-positron emission tomography (PET) is being increasingly used for imaging prostate cancer. Given its greater diagnostic accuracy compared to conventional imaging, there is a strong rationale to evaluate PSMA-PET in imaging mHSPC. Moreover, serial imaging with PSMA-PET may offer a better opportunity to evaluate disease response with systemic therapy and potentially use the results to guide therapy, given that PSMA-targeted radioligand therapy (177Lu-PSMA-617) is now approved for metastatic castrate-resistant prostate cancer (mCRPC). Furthermore, the 6-month timepoint after initiation of systemic therapy is an ideal time to perform interim PSMA-PET given that 6-month prostate specific antigen (PSA) has strong prognostic value in mHSPC in the era of intensified systemic therapy.

This is a prospective trial of 18F-rhPSMA-7.3 PSMA-PET/CT at baseline and after 6 months of therapy for mHSPC, with the aim of evaluating changes in disease extent during this timeframe and correlating this with the PSA response. Results from this pilot study could be used to plan trials assessing (de)intensification of therapy at 6 months based on PSMA-PET.

The primary study objective is to determine the proportion of patients with residual PSMA-avid disease on 18F-rhPSMA-7.3 PSMA-PET after 6 months of therapy for mHSPC.

Exploratory objectives are:

  • To correlate presence/absence of residual PSMA-avid disease after 6 months with PSA ≤0.2 ng/mL at 6 months of therapy.
  • To evaluate changes in SUVmax, SUVmean, total tumor volume and other PET imaging parameters between baseline and 6 months.
  • To evaluate PET imaging parameters at baseline that predict for achievement of PSA ≤0.2 ng/mL at 6 months.
  • To explore use of artificial intelligence (AI) and machine learning (ML) tools in delineating tumor burden and volume on 18F-rhPSMA-7.3 PSMA-PET.

Patients will undergo baseline 18F-rhPSMA-7.3 PSMA-PET/CT and 18F-rhPSMA-7.3 PSMA-PET/CT 6 months after starting treatment for mHSPC with androgen deprivation therapy and androgen receptor pathway inhibitor with or without docetaxel.

Patients will be followed via chart review for 1 year after the 6 month PSMA-PET/CT scan or death, whichever occurs first.

02

Conditions studied

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

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Keywords

  • PSMA
  • PET
  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
  • prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 20 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. 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).
  2. Age ≥18 years.
  3. 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.
  4. Serum testosterone >150 ng/dL.
  5. 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.
  6. Ability and willingness to comply with the study procedures.
  7. 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.
  8. 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.
  9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Radiation to the prostate and/or metastatic sites prior to the 6-month PET scan is not permitted.
  3. 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.
  4. Contraindications to PET/CT, including severe claustrophobia.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-rhPSMA-7.3.
  6. 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.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    PSMA-PET/CT arm

    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

  • Drug18F-rhPSMA-7.3

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

  • DevicePET/CT

    Diagnostic imaging test

06

What researchers measure

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.

    Time frame: 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

07

Study locations

2 sites
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06479187
Lead sponsor
Brigham and Women's Hospital
Collaborators
Dana-Farber Cancer Institute, Blue Earth Diagnostics
Responsible party
Heather A. Jacene, MD (Associate Chief of Nuclear Medicine and Molecular Imaging, Brigham and Women's Hospital) — Principal investigator
First posted
Jun 28, 2024
Start date
Jun 30, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 20, 2027 (estimated)
Last update
Nov 5, 2025

Study contacts

Heather Jacene, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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