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Not yet recruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a short course of bicalutamide changes PSMA, a protein on prostate cancer cells that can be seen on special scans. It is for adults with prostate cancer that has come back, low PSA levels, and cancer in the unfavorable intermediate-risk or high-risk group. Everyone gets a starting PSMA PET/CT scan, and half are chosen by chance to get another scan after 2 weeks of bicalutamide.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be biologically male and at least 18 years old.
  • Have prostate cancer confirmed by a tissue or cell test that has come back based on PSA blood tests. The first diagnosis must be within 2 years before joining.
  • Have cancer in the unfavorable intermediate-risk or high-risk group.
  • Be considered for radiation treatment when cancer first comes back or as treatment after earlier care.
  • If already taking bicalutamide, have started it no more than 3 days before group assignment. Otherwise, at least 42 days off the drug are required.
  • Have a PSA level below 1.0 ng/mL. PSA is a protein measured in blood to help track prostate cancer.
  • Agree to follow the study's lifestyle rules throughout the study.
  • Be able to understand the study and willing to sign a written consent form.

Who can't join

  • Currently receive androgen deprivation therapy, a treatment that lowers or blocks male hormones.
  • Currently receive any other experimental drugs.
  • Have a history of allergic reactions to substances similar to POSLUMA, furosemide, bicalutamide, or other drugs used in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MO

  • Washington University School of Medicine · St Louis, MO 63110Vikas Prasad, MD, PhD · Study contact · 314-632-2812 · pvikas@wustl.eduVikas Prasad, MD, PhD · Principal investigatorFarrokh Dehdashti, MD · Sub-investigatorJeff Michalski, MD · Sub-investigatorMore trials in St Louis