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

Optimizing PSMA Imaging for Enhanced Detection of Residual and Metastatic Prostate Cancer in Low PSA Recurrence (OPERA) Study

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).

Inclusion Criteria:

• 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 Criteria:

• 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.