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

8 september 2026 bijgewerkt door: Washington University School of Medicine

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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Vikas Prasad, MD, PhD
  • Telefoonnummer: 314-632-2812
  • E-mail: pvikas@wustl.edu

Studie Locaties

  • Verenigde Staten
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110
        • Washington University School of Medicine
        • Hoofdonderzoeker:
          • Vikas Prasad, MD, PhD
        • Contact:
        • Onderonderzoeker:
          • Farrokh Dehdashti, MD
        • Onderonderzoeker:
          • Jeff Michalski, MD
        • Onderonderzoeker:
          • Jingqin (Rosy) Luo, PhD
        • Onderonderzoeker:
          • Jade Tao, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Group A: Baseline PSMA PET/CT only with standard of care bicalutamide

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.
Geneesmiddel: 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.
Andere namen:
  • Casodex
Apparaat: 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.
Andere namen:
  • PSMA PET-CT
Geneesmiddel: 18F-rhPSMA-7.3
Radioactive diagnostic agent for intravenous use.
Andere namen:
  • Polsuma
  • Flotufolastat F-18
Diagnostische toets: PROSTest
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
Experimenteel: Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide

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.
Geneesmiddel: 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.
Andere namen:
  • Casodex
Apparaat: 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.
Andere namen:
  • PSMA PET-CT
Geneesmiddel: 18F-rhPSMA-7.3
Radioactive diagnostic agent for intravenous use.
Andere namen:
  • Polsuma
  • Flotufolastat F-18
Diagnostische toets: PROSTest
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Group B only: Lesion detection rates between PET1 and PET2.
Tijdsspanne: 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).
Baseline and 14 days after start of bicalutamide treatment (total estimated time 14 days)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Group A and B: Number of lesions detected on early scan versus delayed scan
Tijdsspanne: 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).
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
Tijdsspanne: 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.
Through day 90
Group A and B: Comparison of PSA response in patients who are treated with radiation vs. those treated with radiation
Tijdsspanne: 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.
Through day 90
Group B only: Correlation between PSA kinetics and detection rates between PET1 and PET2
Tijdsspanne: 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.
Through day 90
Group B only: Correlation between PROSTest results and detection rates of PET1 and PET2
Tijdsspanne: 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.
14 days after start of bicalutamide treatment (total estimated time 14 days)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Washington University School of Medicine

Medewerkers

The Society of Nuclear Medicine and Molecular Imaging

Onderzoekers

  • Hoofdonderzoeker: Vikas Prasad, MD, PhD, Washington University School of Medicine

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

31 oktober 2026

Primaire voltooiing (Geschat)

14 november 2027

Studie voltooiing (Geschat)

31 januari 2028

Studieregistratiedata

Eerst ingediend

11 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 mei 2026

Eerst geplaatst (Werkelijk)

18 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 september 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 202604224

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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