Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer
8 septembre 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Vikas Prasad, MD, PhD
- Numéro de téléphone: 314-632-2812
- E-mail: pvikas@wustl.edu
Lieux d'étude
-
-
Missouri
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St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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Chercheur principal:
- Vikas Prasad, MD, PhD
-
Contact:
- Vikas Prasad, MD, PhD
- Numéro de téléphone: 314-632-2812
- E-mail: pvikas@wustl.edu
-
Sous-enquêteur:
- Farrokh Dehdashti, MD
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Sous-enquêteur:
- Jeff Michalski, MD
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Sous-enquêteur:
- Jingqin (Rosy) Luo, PhD
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Sous-enquêteur:
- Jade Tao, PhD
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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. |
Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally.
This is given as standard of care.
Autres noms:
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.
Autres noms:
Radioactive diagnostic agent for intravenous use.
Autres noms:
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
|
|
Expérimental: 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. |
Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally.
This is given as standard of care.
Autres noms:
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.
Autres noms:
Radioactive diagnostic agent for intravenous use.
Autres noms:
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Group B only: Lesion detection rates between PET1 and PET2.
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Group A and B: Number of lesions detected on early scan versus delayed scan
Délai: 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
Délai: 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
|
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Group A and B: Comparison of PSA response in patients who are treated with radiation vs. those treated with radiation
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Vikas Prasad, MD, PhD, Washington University School of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
31 octobre 2026
Achèvement primaire (Estimé)
14 novembre 2027
Achèvement de l'étude (Estimé)
31 janvier 2028
Dates d'inscription aux études
Première soumission
11 mai 2026
Première soumission répondant aux critères de contrôle qualité
11 mai 2026
Première publication (Réel)
18 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202604224
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .