Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-rhPSMA-7.3 | Drug | — | UNRESOLVED |
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography | Device | — | UNRESOLVED |
| PROSTest | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A: Baseline PSMA PET/CT only with standard of care bicalutamide
- description
- Patients will undergo baseline PSMA PET/CT (PET1) with 18F-rhPSMA-7.3 (F-18 flotufolastat, Posluma). After the 18F-rhPSMA-7.3 injection, patients will undergo research imaging consisting of 5 minutes of PET imaging, followed by routine imaging at 60 minutes after 18F-rhPSMA-7.3 injection. Patients will have blood collected for PROSTest and PSA within 1 day of completion of PET1. Following PET1, patients will initiate standard of care bicalutamide for a minimum of 14 days, with the first dose taken the day after PET1. Patients will undergo a 90 day follow-up visit (relative to PET1) for collection of blood for PROSTest and PSA.
- interventionNames
- Drug: Bicalutamide
- Device: Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography
- Drug: 18F-rhPSMA-7.3
- Diagnostic Test: PROSTest
- type
- EXPERIMENTAL
- label
- Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide
- description
- Patients will undergo baseline PSMA PET/CT (PET1) with 18F-rhPSMA-7.3 (F-18 flotufolastat, Posluma). After the 18F-rhPSMA-7.3 injection, patients will undergo research imaging consisting of 5 minutes of PET imaging, followed by routine imaging at 60 minutes after 18F-rhPSMA-7.3 injection. Patients will have blood collected for PROSTest and PSA within 1 day of completion of PET1. Following PET1, patients will initiate standard of care bicalutamide for a minimum of 14 days, with the first dose taken the day after PET1 and will undergo a research PSMA PET/CT (PET2) on Day 14 (±3 days). The research PSMA PET/CT (PET2) will follow the same imaging procedures as the baseline PET. Patients will undergo a 90 day follow-up visit (relative to PET1) for collection of blood for PROSTest and PSA.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available