Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer
8 de setembro de 2026 atualizado por: 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).
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Vikas Prasad, MD, PhD
- Número de telefone: 314-632-2812
- E-mail: pvikas@wustl.edu
Locais de estudo
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
-
Investigador principal:
- Vikas Prasad, MD, PhD
-
Contato:
- Vikas Prasad, MD, PhD
- Número de telefone: 314-632-2812
- E-mail: pvikas@wustl.edu
-
Subinvestigador:
- Farrokh Dehdashti, MD
-
Subinvestigador:
- Jeff Michalski, MD
-
Subinvestigador:
- Jingqin (Rosy) Luo, PhD
-
Subinvestigador:
- Jade Tao, PhD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
Outros nomes:
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.
Outros nomes:
Radioactive diagnostic agent for intravenous use.
Outros nomes:
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
|
|
Experimental: 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.
Outros nomes:
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.
Outros nomes:
Radioactive diagnostic agent for intravenous use.
Outros nomes:
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Group B only: Lesion detection rates between PET1 and PET2.
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Group A and B: Number of lesions detected on early scan versus delayed scan
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Vikas Prasad, MD, PhD, Washington University School of Medicine
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
31 de outubro de 2026
Conclusão Primária (Estimado)
14 de novembro de 2027
Conclusão do estudo (Estimado)
31 de janeiro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
11 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de maio de 2026
Primeira postagem (Real)
18 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202604224
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Sim
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .