Prostate CancerCZECH-PSMANCT07608419
Predictors of Nodal and Distant Metastatic Disease Detected by PSMA PET in Treatment-Naïve High-Risk Prostate Cancer: A Czech Multicentre Cohort Study
An observational study of Prostate Cancer and High Risk Prostate Cancer, run by General University Hospital, Prague.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, High Risk Prostate Cancer, PSMA PET
- What is being tested?
- PSMA PET
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- PSMA PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PETDiagnostic test
PSMA PET with different the use radiotracers as primary staging of high risk localized or locally advanced PCa
| Study group | Role | What they receive |
|---|---|---|
| High-risk localized or locally advanced PCa before treatment | Not described Receives: Diagnostic Test: PSMA PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: At the time of surgery (approximately 2-6 weeks post-imaging).
Prognostic Value of Combined Molecular and Clinicopathological Markers for Early Oncological Outcomes
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.
Measured: From the date of treatment with curative intent up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Nemocnice České Budějovice, České Budějovice, Czechia, University Hospital Olomouc, County Hospital Liberec, Liberec, Czech Republic, University Hospital, Motol, Ústřední fakultní vojenská nemocnice, Praha, Czechia, Masaryk University
- Responsible party
- Principal investigator, doc. MUDr. Otakar Čapoun, Ph.D., FEBU, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608419
- Sponsor's protocol ID
- 49/26 S-IV
- Acronym
- CZECH-PSMA
- Status last verified
- May 2026
- First submitted
- 2 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If asked for other studies e.g. systematic review and metaanalysis.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Nodal and Distant Metastatic Disease Detected by PSMA PET in Treatment-Naïve High-Risk Prostate Cancer: A Czech Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT07608419
- Acronym / sponsor ID
- CZECH-PSMA / 49/26 S-IV
- Conditions
- Prostate Cancer, High Risk Prostate Cancer, PSMA PET, Staging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Collaborators
- Nemocnice České Budějovice, České Budějovice, Czechia, University Hospital Olomouc, County Hospital Liberec, Liberec, Czech Republic, University Hospital, Motol, Ústřední fakultní vojenská nemocnice, Praha, Czechia, Masaryk University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk localized or locally advanced PCa before treatment | – | Diagnostic Test: PSMA PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA PETPSMA PET with different the use radiotracers as primary staging of high risk localized or locally advanced PCa | Diagnostic test | High-risk localized or locally advanced PCa before treatment |
Primary outcome
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.
Time frame: 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.
2 secondary outcomes
Rate of miT and miN stage migration between PSMA PET (according to PROMISE V2) and final histopathology from radical prostatectomy.
Time frame: At the time of surgery (approximately 2-6 weeks post-imaging).
Prognostic Value of Combined Molecular and Clinicopathological Markers for Early Oncological Outcomes
Time frame: From the date of treatment with curative intent up to 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Yes. If asked for other studies e.g. systematic review and metaanalysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and High Risk Prostate Cancer, run by General University Hospital, Prague.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Data collected at the time of result of PSMA PET/CT imaging, approximately 1 month after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.