Predictors of Nodal and Distant Metastatic Disease Detected by PSMA PET in Treatment-Naïve High-Risk Prostate Cancer: A Czech Multicentre Cohort Study

NCT07608419 | Active Not Recruiting

• 1 other identifier: 49/26 S-IV
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer; High Risk Prostate Cancer; PSMA PET; Staging

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (2)

• Rate of miT and miN stage migration between PSMA PET (according to PROMISE V2) and final histopathology from radical prostatectomy.

  At the time of surgery (approximately 2-6 weeks post-imaging).

• Prognostic Value of Combined Molecular and Clinicopathological Markers for Early Oncological Outcomes

  From the date of treatment with curative intent up to 10 years.

Other Outcomes (4)

• Frequency of clinical management changes based on PSMA PET/CT compared to conventional 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

  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

  At the time of surgery (approximately 2-6 weeks post-imaging)

Study Arms (1)

High-risk localized or locally advanced PCa before treatment

Diagnostic Test: PSMA PET

Interventions

PSMA PET DIAGNOSTIC_TEST

PSMA PET with different the use radiotracers as primary staging of high risk localized or locally advanced PCa

High-risk localized or locally advanced PCa before treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• General University Hospital, Prague: lead
• Nemocnice České Budějovice, České Budějovice, Czechia: collaborator
• University Hospital Olomouc: collaborator
• County Hospital Liberec, Liberec, Czech Republic: collaborator
• University Hospital, Motol: collaborator
• Ústřední fakultní vojenská nemocnice, Praha, Czechia: collaborator
• Masaryk University: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MUDr. Martin Malý

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: May 27, 2026
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share