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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. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

400

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
High-risk localized or locally advanced PCa before treatment
Diagnostický test: PSMA PET
PSMA PET with different the use radiotracers as primary staging of high risk localized or locally advanced PCa

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Rate of miT and miN stage migration between PSMA PET (according to PROMISE V2) and final histopathology from radical prostatectomy.
Časové okno: 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
Časové okno: 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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Frequency of clinical management changes based on PSMA PET/CT compared to conventional imaging
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

General University Hospital, Prague

Spolupracovníci

University Hospital Olomouc
Ústřední fakultní vojenská nemocnice, Praha, Czechia
Nemocnice České Budějovice, České Budějovice, Czechia
Masaryk University
University Hospital, Motol
County Hospital Liberec, Liberec, Czech Republic

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. ledna 2016

Primární dokončení (Odhadovaný)

1. prosince 2026

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

2. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

19. května 2026

První zveřejněno (Aktuální)

27. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 49/26 S-IV

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

If asked for other studies e.g. systematic review and metaanalysis.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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