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

Starting soon · Phase 2

Conditions studied: Prostate Cancer, Recurrent Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic

In brief

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 facts

Study ID

NCT07593079

Run by

Washington University School of Medicine

People needed

20

Starts

2026-07-31

Expected to finish

2027-10-31

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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