Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07593079
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Prostate Cancer
  • Prostate Cancer
  • Prostate Cancer Metastatic
  • Prostate Cancer Recurrent
  • Recurrent Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bicalutamide — DRUG
    Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care.
  • Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography — DEVICE
    Patients will undergo prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography (PSMA PET-CT) imaging. Each PSMA PET-CT session will consist of 5 minutes of dynamic imaging conducted via the Biograph Vision Quadra PET-CT, a whole-body PET-CT scanner.
  • 18F-rhPSMA-7.3 — DRUG
    Radioactive diagnostic agent for intravenous use.
  • PROSTest — DIAGNOSTIC_TEST
    PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.

Study Details

This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng/mL and who have undergone complete prostatectomy and/or will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET/CT only with bicalutamide standard of care) or Group B (baseline PSMA PET/CT and an additional PSMA PET/CT after 2 weeks of bicalutamide).

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jul 14, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Group A: Baseline PSMA PET/CT only with standard of care bicalutamide
    Patients will undergo baseline PSMA PET/CT (PET1) with 18F-rhPSMA-7.3 (F-18 flotufolastat, Posluma). After the 18F-rhPSMA-7.3 injection, patients will undergo research imaging consisting of 5 minutes of PET imaging, followed by routine imaging at 60 minutes after 18F-rhPSMA-7.3 injection. Patients will have blood collected for PROSTest and PSA within 1 day of completion of PET1. Following PET1, patients will initiate standard of care bicalutamide for a minimum of 14 days, with the first dose taken the day after PET1. Patients will undergo a 90 day follow-up visit (relative to PET1) for collection of blood for PROSTest and PSA.
  • Experimental: Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide
    Patients will undergo baseline PSMA PET/CT (PET1) with 18F-rhPSMA-7.3 (F-18 flotufolastat, Posluma). After the 18F-rhPSMA-7.3 injection, patients will undergo research imaging consisting of 5 minutes of PET imaging, followed by routine imaging at 60 minutes after 18F-rhPSMA-7.3 injection. Patients will have blood collected for PROSTest and PSA within 1 day of completion of PET1. Following PET1, patients will initiate standard of care bicalutamide for a minimum of 14 days, with the first dose taken the day after PET1 and will undergo a research PSMA PET/CT (PET2) on Day 14 (±3 days). The research PSMA PET/CT (PET2) will follow the same imaging procedures as the baseline PET. Patients will undergo a 90 day follow-up visit (relative to PET1) for collection of blood for PROSTest and PSA.

Primary Outcome Measure

Group B only: Lesion detection rates between PET1 and PET2. [ Time Frame: Baseline and 14 days after start of bicalutamide treatment (total estimated time 14 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Vikas Prasad, MD, PhD
[email protected]
314-632-2812
Vikas Prasad, MD, PhD (PRINCIPAL_INVESTIGATOR)
Farrokh Dehdashti, MD (SUB_INVESTIGATOR)
Jeff Michalski, MD (SUB_INVESTIGATOR)
Jingqin (Rosy) Luo, PhD (SUB_INVESTIGATOR)
Jade Tao, PhD (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

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Prostate cancer
By specialty
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By research site
Washington University School of Medicine· St Louis, MO

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