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PSMA Imaging for Recurrent Prostate Cancer

This study is looking at how a short course of bicalutamide, a standard prostate cancer medication, affects how prostate cancer cells show up on a special type of scan called PSMA PET-CT (Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography). This scan helps doctors find prostate cancer that has come back or spread. We are looking for men with prostate cancer that has returned after treatment, especially those with intermediate unfavorable or high-risk cancer and low PSA (Prostate-specific antigen) levels. Participants will receive bicalutamide and undergo PSMA PET-CT scans. The study aims to see if bicalutamide changes how well the PSMA PET-CT can detect cancer lesions. The current status of this study is unclear.

Study design
This is a randomized, open-label pilot study with 20 participants. Participants will be split into two groups: one receiving a baseline PSMA PET/CT, and the other receiving a baseline and a second PSMA PET/CT after two weeks of bicalutamide.
What's involved
You would take bicalutamide daily and undergo at least one PSMA PET-CT scan. Some participants will have a second PSMA PET-CT scan after 14 days of bicalutamide treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at baseline and 14 days after starting bicalutamide treatment, for a total estimated time of 14 days.

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NCT07593079

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Washington University School of Medicine
~20 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:BicalutamideProstate-specific membrane antigen Positron Emission Tomography-Computed Tomography18F-rhPSMA-7.3PROSTest

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Group B only: Lesion detection rates between PET1 and PET2.
Measured over Baseline and 14 days after start of bicalutamide treatment (total estimated time 14 days)

Conditions

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

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Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Vikas Prasad, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Vikas Prasad, MD, PhD
[email protected]
314-632-2812
Email the study team

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed biochemically recurrent prostate cancer, with original diagnosis no more than 2 years from date of consent.
Intermediate unfavorable or high-risk prostate cancer.
All patients under consideration for radiation therapy, either at the time of first recurrence or in salvage radiation therapy will be included.
Patients who have started bicalutamide up to a maximum of 3 days prior to randomization will be allowed to be on protocol. Otherwise, a washout period of at least 42 days will be required.
Biological males, at least 18 years of age.
Prostate specific antigen (PSA) \< 1.0 ng/mL.
Agreement to adhere to Lifestyle Considerations throughout study duration
Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion

Patients currently on androgen deprivation therapy (ADTs).
Currently receiving any other investigational agents.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to POSLUMA, furosemide, bicalutamide, or other agents used in the study.

What this trial measures

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

    Differences in lesion detection rates between Group B PET1 and PET2 will be analyzed by McNemar's test. Lesion detection rates will be reported by Group B patients at PET1 and PET2 scans and by the two scan sets (first 5 minutes and at 60 minutes post 18F-rhPSMA-7.3 injection).