Predictors of Nodal and Distant Metastatic Disease Detected by PSMA PET in Treatment-Naïve High-Risk Prostate Cancer: A Czech Multicentre Cohort Study (CZECH-PSMA)
19 de maio de 2026 atualizado por: doc. MUDr. Otakar Čapoun, Ph.D., FEBU, General University Hospital, Prague
Prostate cancer is the second most common malignancy worldwide and the fifth leading cause of male cancer-related mortality.
Approximately 15% of localized cases are classified as high-risk for biochemical recurrence.
These patients frequently harbour occult metastases undetected by conventional imaging (CT and bone scintigraphy).
Consequently, PSMA PET has revolutionized primary staging and is strongly recommended by EAU guidelines.
In the Czech Republic, a transition toward a "PSMA-first" pathway is evident, where molecular imaging increasingly replaces conventional modalities.
This "stage-migration" identifies a new cohort of miN1/M1 patients previously classified as having localized disease.
However, PSMA PET is a resource-demanding modality and not yet universally available.
To optimize its utility, identifying which combinations of routinely available parameters predict metastatic disease and characterizes this new cohort is essential.
Furthermore, real-world evidence regarding early oncological outcomes within this PSMA-only framework is limited.
This multicentre cohort study aims to define a multiparametric predictive model for PSMA-detected metastases and evaluate the real-world therapeutic trajectories and follow-up outcomes of this newly defined high-risk population.
Integrating clinical, biological, and molecular data, seeks to refine patient selection and provide a longitudinal perspective on the "PSMA-first" diagnostic era.
Visão geral do estudo
Status
Ativo, não recrutando
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Estimado)
400
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
Método de amostragem
Amostra Não Probabilística
População do estudo
Persons: Male patients aged ≥ 18 years with histologically confirmed prostate adenocarcinoma. Place: The Czech Republic, including patients diagnosed and treated in Urological and ahiliated Nuclear Medicine Departments.
Time period (Study Window): January 1, 2016 to December 31, 2025, capturing the transition toward molecular imaging in primary staging.
Selection Criteria: Patients with histologically confirmed high-risk prostate cancer according to EAU guidelines who underwent primary staging with PSMA PET within the study window.
Descrição
Inclusion Criteria
Male patients will be included if:
- Male patients aged ≥ 18 years with histologically confirmed prostate adenocarcinoma,
- high-risk disease defined as ISUP GG ≥ 4 and/or PSA ≥ 20 ng/ml and/or clinical stage assessed by DRE ≥ cT2c,
- PSMA PET performed for primary staging within study window.
Exclusion Criteria
Patients with:
- definitive local treatment (e.g., radical prostatectomy or radiation therapy) or systemic treatment (e.g., androgen deprivation therapy) administered prior to primary staging with PSMA PET,
- low or intermediate-risk PCa as defined by failing to meet any of the inclusionary high-risk parameters,
- incomplete or fragmented medical records that preclude the accurate extraction of primary staging parameters (PSA, ISUP GG, clinical T-stage) or PSMA PET results (miN/miM status),
- active malignancy requiring systemic treatment at the time of PSMA PET.
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
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
High-risk localized or locally advanced PCa before treatment
|
PSMA PET with different the use radiotracers as primary staging of high risk localized or locally advanced PCa
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Area Under the Receiver Operating Characteristic (AUC ROC) [scale 0 to 1] of multiparametric model for miN1 and/or miM1 on PSMA (prostate specific membrane antigen) PET (positron emission tomography) according to PROMISE (prostate cancer) V2 criteria.
Prazo: Data collected at the time of result of PSMA PET/CT imaging, approximately 1 month after.
|
This predictive model aggregates heterogeneous predictors into a single numerical probability score to determine the presence of metastasis by multivariate logistical regression.
The model will include: serum PSA (prostate specific antigen) [μg/ml] and/or PSA density [μg/ml/cc], clinical T stage [T1a/b/c, T2a/b/c, T3a/b, T4], prostate biopsy ISUP GG - International Society of Urology Pathology Grade Group [1/2/3/4/5], and the presence of a cribriform growth pattern, multiparametric MRI (magnetic resonance imaging) PI-RADS (Prostate Imaging Reporting and Data System) v2.1 score [1/2/3/4/5], as well as SUVmax (maximum standardized uptake value) [g/ml] and PSMA PET total tumor volume [ml] of the primary intraprostatic lesion.
Higher scores/values indicate more aggressive disease.
|
Data collected at the time of result of PSMA PET/CT imaging, approximately 1 month after.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Rate of miT and miN stage migration between PSMA PET (according to PROMISE V2) and final histopathology from radical prostatectomy.
Prazo: At the time of surgery (approximately 2-6 weeks post-imaging).
|
The proportion of participants whose pathological stage pT and pN differs from the molecular imaging stage miT and miN.
Upstaging: Percentage of cases where pathology reveals more advanced disease than PET (e.g., miT2 to pT3a).
Downstaging: Percentage of cases where pathology reveals less extensive disease than PET (e.g., miN1 to pN0).
Total Concordance: Percentage of cases where miT/N and pT/N are identical.
|
At the time of surgery (approximately 2-6 weeks post-imaging).
|
|
Prognostic Value of Combined Molecular and Clinicopathological Markers for Early Oncological Outcomes
Prazo: From the date of treatment with curative intent up to 10 years.
|
Evaluation of the combined predictive utility of PSMA SUVmax (maximum standardized uptake value) [g/ml] and / or phi (the Prostate Health Index) and / or the presence of a cribriform growth pattern for forecasting early oncological outocmes including biochemical persistence (defined as PSA ≥ 0.1 ng/mL at 6-8 weeks post-surgery) and biochemical recurrence (defined as two consecutive PSA values ≥ 0.2 ng/mL after radical prostatectomy or ≥ 2 ng/mL above nadir after radical radiotherapy).
The study also measures the impact of these integrated parameters on progression-free survival and overall survival.
Predictive accuracy is quantified through multivariable modeling to determine the additive value of molecular imaging over standard clinical parameters.
|
From the date of treatment with curative intent up to 10 years.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Frequency of clinical management changes based on PSMA PET/CT compared to conventional imaging
Prazo: From the date of initial conventional imaging to the initiation of the final treatment plan (approximately 4-12 weeks).
|
This measure assesses the proportion of participants whose treatment plan is modified following PSMA PET/CT staging relative to the strategy established by conventional imaging.
A management change is defined as a transition in clinical intent, such as moving from local curative therapy to systemic treatment due to the discovery of metastatic disease.
The study records the rate at which molecular imaging findings lead to a change in the final management decision compared to standard-of-care imaging.
|
From the date of initial conventional imaging to the initiation of the final treatment plan (approximately 4-12 weeks).
|
|
Rate of interobserver agreement between local and central expert reviews using standardized PROMISE V2 criteria
Prazo: From the date of initial imaging until the completion of centralized review (approximately 3 months).
|
The level of consistency between local site investigators and central expert reviewers is assessed through the comparison of PSMA PET/CT molecular staging findings.
Agreement is quantified using Cohen's kappa coefficient to evaluate the reproducibility of the PROMISE V2 criteria.
|
From the date of initial imaging until the completion of centralized review (approximately 3 months).
|
|
Predictive accuracy of preoperative markers for adverse pathological features at radical prostatectomy
Prazo: At the time of surgery (approximately 2-6 weeks post-imaging)
|
This measure assesses the ability of PSMA PET findings (SUVmax of prostate and seminal vesicles and / or total PSMA volume) and clinical parameters (PSA-D and / or cribriform pattern) to predict the presence of high-risk disease features in the final surgical specimen.
Adverse pathological features are defined as the presence of pT3 (pathological T stage 3) and final ISUP (International Society of Urological Pathology) Grade Group ≥ 4, or pelvic lymph node metastasis (pN1).
The predictive performance is reported using the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity to quantify the diagnostic accuracy of preoperative staging compared to the gold-standard histopathology.
|
At the time of surgery (approximately 2-6 weeks post-imaging)
|
|
Rate of biochemical recurrence-free survival in the oligometastatic subgroup of this cohort primarly staged with PSMA PET
Prazo: From the date of primary treatment up to 10 years.
|
This outcome measure determines the proportion of participants in the oligometastatic subgroup who remain free of biochemical recurrence following primary treatment.
Biochemical recurrence is defined as the occurrence of two consecutive PSA values ≥ 0.2 ng/mL.
By aggregating these clinical, diagnostic, and oncological parameters, the study evaluates the total impact of PSMA PET/CT on the standard of care and its influence on subsequent clinical management.
|
From the date of primary treatment up to 10 years.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este 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 (Real)
1 de janeiro de 2016
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
2 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de maio de 2026
Primeira postagem (Real)
27 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 49/26 S-IV
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
If asked for other studies e.g.
systematic review and metaanalysis.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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