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NCT Number: NCT07593079

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

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostate Cancer Neoplasms Neoplasms by Site Prostate Cancer Metastatic Prostate Cancer Recurrent Prostatic Diseases Prostatic Neoplasms Recurrent Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location contact

Farrokh Dehdashti, MD

SUB_INVESTIGATOR

Jade Tao, PhD

SUB_INVESTIGATOR

Jeff Michalski, MD

SUB_INVESTIGATOR

Jingqin (Rosy) Luo, PhD

SUB_INVESTIGATOR

Vikas Prasad, MD, PhD

CONTACT

[email protected]

314-632-2812

Vikas Prasad, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bicalutamide

Drug

Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care.

Other names: Casodex

Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography

Device

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.

Other names: PSMA PET-CT

18F-rhPSMA-7.3

Drug

Radioactive diagnostic agent for intravenous use.

Other names: Polsuma, Flotufolastat F-18

PROSTEST

Diagnostic Test

PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

    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).

  2. Group A and B: Correlation between PSA response and PROSTest after radiation therapy

    Time frame: Through day 90

    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.

  3. 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

    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.

  4. Group B only: Correlation between PSA kinetics and detection rates between PET1 and PET2

    Time frame: Through day 90

    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.

  5. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Vikas Prasad, MD, PhD

CONTACT

[email protected]

314-632-2812

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Society of Nuclear Medicine and Molecular Imaging

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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