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

8 september 2026 uppdaterad av: 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).

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

20

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Vikas Prasad, MD, PhD
  • Telefonnummer: 314-632-2812
  • E-post: pvikas@wustl.edu

Studieorter

  • Förenta staterna
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine
        • Huvudutredare:
          • Vikas Prasad, MD, PhD
        • Kontakt:
        • Underutredare:
          • Farrokh Dehdashti, MD
        • Underutredare:
          • Jeff Michalski, MD
        • Underutredare:
          • Jingqin (Rosy) Luo, PhD
        • Underutredare:
          • Jade Tao, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Läkemedel: 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.
Andra namn:
  • Casodex
Enhet: 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.
Andra namn:
  • PSMA PET-CT
Läkemedel: 18F-rhPSMA-7.3
Radioactive diagnostic agent for intravenous use.
Andra namn:
  • Polsuma
  • Flotufolastat F-18
Diagnostiskt test: PROSTest
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • Casodex
Enhet: 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.
Andra namn:
  • PSMA PET-CT
Läkemedel: 18F-rhPSMA-7.3
Radioactive diagnostic agent for intravenous use.
Andra namn:
  • Polsuma
  • Flotufolastat F-18
Diagnostiskt test: PROSTest
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Group B only: Lesion detection rates between PET1 and PET2.
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Group A and B: Number of lesions detected on early scan versus delayed scan
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Washington University School of Medicine

Samarbetspartners

The Society of Nuclear Medicine and Molecular Imaging

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 oktober 2026

Primärt slutförande (Beräknad)

14 november 2027

Avslutad studie (Beräknad)

31 januari 2028

Studieregistreringsdatum

Först inskickad

11 maj 2026

Först inskickad som uppfyllde QC-kriterierna

11 maj 2026

Första postat (Faktisk)

18 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 202604224

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

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