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Not yet recruiting NCT07593079

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

Phase II Interventional Prostate Cancer Recurrent Prostate Cancer Metastatic Prostate Cancer Prostate Cancer Recurrent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bicalutamide, Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography, 18F-rhPSMA-7.3, PROSTest.
Who it may be relevant to
Registry conditions: Prostate Cancer, Recurrent Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer Recurrent. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • Drug Bicalutamide
    Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care.
  • Device Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography
    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.
  • Drug 18F-rhPSMA-7.3
    Radioactive diagnostic agent for intravenous use.
  • Diagnostic test PROSTest
    PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.

Primary outcome measures

  • 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)]
Secondary outcome measures (5)
  • Group A and B: Number of lesions detected on early scan versus delayed scan [Time frame: At baseline and 14 days after start of bicalutamid treatment (total estimated time is 14 days)]
  • Group A and B: Correlation between PSA response and PROSTest after radiation therapy [Time frame: Through day 90]
  • Group A and B: Comparison of PSA response in patients who are treated with radiation vs. those treated with radiation [Time frame: Through day 90]
  • Group B only: Correlation between PSA kinetics and detection rates between PET1 and PET2 [Time frame: Through day 90]
  • Group B only: Correlation between PROSTest results and detection rates of PET1 and PET2 [Time frame: 14 days after start of bicalutamide treatment (total estimated time 14 days)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07593079 · 202604224

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗