Active — Not RecruitingNot Applicable

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

400 participantsStarted 2016-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Data collected at the time of result of PSMA PET/CT imaging, approximately 1 month after.

Trial details

NCT IDNCT07608419

SponsorGeneral University Hospital, Prague

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

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