Prostate CancerPhase 2NCT07593079
Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer
A Phase 2 study testing Bicalutamide, Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography and 18F-rhPSMA-7.3 in people with Prostate Cancer and Recurrent Prostate Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Recurrent Prostate Cancer, Metastatic Prostate Cancer
- What is being tested?
- Bicalutamide, Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography and 18F-rhPSMA-7.3
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
Vikas Prasad, MD, PhD, 314-632-2812, pvikas@wustl.edu
Vikas Prasad, MD, PhD
About this study
Official title: 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).
- Conditions
- Prostate Cancer, Recurrent Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic
- Being tested
- Bicalutamide, Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography, 18F-rhPSMA-7.3, PROSTest
- Keywords
- Prostate cancer, Low PSA, PSMA PET, BCR, Bicalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called Casodex
Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care.
Prostate-specific membrane antigen Positron Emission Tomography-Computed TomographyDevice
Also called PSMA PET-CT
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.
18F-rhPSMA-7.3Drug
Also called Polsuma, Flotufolastat F-18
Radioactive diagnostic agent for intravenous use.
PROSTestDiagnostic test
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Baseline PSMA PET/CT only with standard of care bicalutamide | Active comparator | 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. Receives: Drug: Bicalutamide; Device: Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography; Drug: 18F-rhPSMA-7.3; Diagnostic Test: PROSTest |
| Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide | Experimental | 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. Receives: Drug: Bicalutamide; Device: Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography; Drug: 18F-rhPSMA-7.3; Diagnostic Test: PROSTest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group B only: Lesion detection rates between PET1 and PET2.
Differences in lesion detection rates between Group B PET1 and PET2 will be analyzed by McNemar's test. Lesion detection rates will be reported by Group B patients at PET1 and PET2 scans and by the two scan sets (first 5 minutes and at 60 minutes post 18F-rhPSMA-7.3 injection).
Measured: Baseline and 14 days after start of bicalutamide treatment (total estimated time 14 days)
Secondary outcomes (5)
Group A and B: Number of lesions detected on early scan versus delayed scan
The total number of lesions detected per patient will be summarized as counts. The number of lesions will be summarized by descriptive statistics for all patients at PET1, Group A patients at PET1, Group B patients at PET1, and Group B patients at PET2 and for each, by the two scan sets (early scan = first 5 minutes and at delayed scan = 60 minutes post 18F-rhPSMA-7.3 injection).
Measured: 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
The correlation between PSA response and PROSTest after radiation therapy will be analyzed in Group A versus Group B. The results will be reported as a two-sample t-test or Wilcoxon sum rank test.
Measured: Through day 90
Group A and B: Comparison of PSA response in patients who are treated with radiation vs. those treated with radiation
The comparison of PSA response will be analyzed in patients who are treated with radiation based on results of the PET2 versus those treated with radiation based on the results of PET1. The comparison will be reported as the results of a two-sample t-test or Wilcoxon sum rank test.
Measured: Through day 90
Group B only: Correlation between PSA kinetics and detection rates between PET1 and PET2
The correlation between PSA kinetics and detection rates will be reported as the results of a two sample t-test or Wilcoxon sum rank test for each timepoint, PET1 and PET2.
Measured: Through day 90
Group B only: Correlation between PROSTest results and detection rates of PET1 and PET2
Correlation between PROSTest results and detection rates of PET1 and PET2 will be reported as two sample t-test or Wilcoxon sum rank test. Results will be reported for PET1 and PET2.
Measured: 14 days after start of bicalutamide treatment (total estimated time 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start31 Oct 2026 (estimated)
- Primary completion14 Nov 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Society of Nuclear Medicine and Molecular Imaging
- Responsible party
- Sponsor
- Investigators
- Vikas Prasad, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593079
- Sponsor's protocol ID
- 202604224
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing PSMA Imaging for Enhanced Detection of Residual and Metastatic Prostate Cancer in Low PSA Recurrence (OPERA) Study
- ClinicalTrials.gov ID
- NCT07593079
- Acronym / sponsor ID
- 202604224
- Conditions
- Prostate Cancer, Recurrent Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic
- Keywords
- Prostate cancer, Low PSA, PSMA PET, BCR, Bicalutamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Society of Nuclear Medicine and Molecular Imaging
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 14 Nov 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Baseline PSMA PET/CT only with standard of care bicalutamide | Active comparator | Drug: Bicalutamide, Device: Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography, Drug: 18F-rhPSMA-7.3, Diagnostic Test: PROSTestPatients 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. |
| Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide | Experimental | Drug: Bicalutamide, Device: Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography, Drug: 18F-rhPSMA-7.3, Diagnostic Test: PROSTestPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BicalutamideAlso: CasodexBicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care. | Drug | Group A: Baseline PSMA PET/CT only with standard of care bicalutamide, Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide |
| Prostate-specific membrane antigen Positron Emission Tomography-Computed TomographyAlso: PSMA PET-CTPatients 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. | Device | Group A: Baseline PSMA PET/CT only with standard of care bicalutamide, Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide |
| 18F-rhPSMA-7.3Also: Polsuma, Flotufolastat F-18Radioactive diagnostic agent for intravenous use. | Drug | Group A: Baseline PSMA PET/CT only with standard of care bicalutamide, Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide |
| PROSTestPROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments. | Diagnostic test | Group A: Baseline PSMA PET/CT only with standard of care bicalutamide, Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide |
Primary outcome
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)
Differences in lesion detection rates between Group B PET1 and PET2 will be analyzed by McNemar's test. Lesion detection rates will be reported by Group B patients at PET1 and PET2 scans and by the two scan sets (first 5 minutes and at 60 minutes post 18F-rhPSMA-7.3 injection).
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vikas Prasad, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicalutamide, Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography and 18F-rhPSMA-7.3 in people with Prostate Cancer and Recurrent Prostate Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vikas Prasad, MD, PhD (314-632-2812, pvikas@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.