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
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
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:
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.
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 →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.
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Exclusion Criteria:
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
radiopharmaceutical targeting PSMA and used to image prostate cancer with PET scan.
Diagnostic imaging test
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
Plan to share: No
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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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