Clinical trial · Observational
Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer
NCT07645391CI-TRIAL-00114556recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates urinary biomarkers and PSA to help determine the best approach to early detection of prostate cancer in patients with an elevated familial risk.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo urine and blood sample collection, provide family history of cancer and have their medical records reviewed throughout the study. Patients also undergo a digital rectal examination, complete a questionnaire and receive results of the PSA blood test and urine biomarker test. Patients with an elevated PSA level above 2.0 ng/ml (age 40-49) or 2.5 ng/ml (age 50-70) or abnormal urine test will be referred for an ultrasound-guided biopsy of the prostate gland.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (1)
- measure
- Predictors of any HG PCa
- timeFrame
- At 5-years follow up
- description
- Descriptive statistics, parametric and non-parametric statistical tests will be used to summarize the clinical variables. Will estimate the prevalence and incidence. Will fit two statistical models with cross-validation to evaluate the performance characteristics (Brier score, area under curve, sensitivity, specificity, positive and negative predictive values) of SelectMDx in predicting i) HG PCa and ii) any PCa.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:
* \* Age 35-70 years
* Capable of providing informed consent
* Prognosis of \> 5 years if affected by another cancer
* Patients need one to meet at least one of the following high genetic risk categories:
* Known PCa-related mutations: BRCA 1 and 2, Lynch syndrome, or p53
* Carrier of mutation in a suspected PCa-related gene: e.g., ATM, PALB2, CHEK2, RAD51D, ATR, NBN, GEN1, RAD51C, MRE11A, BRIP1, FAM175A, HOXB13
* Obligate carriers of the above mutations (e.g. their sisters/daughters have known mutations)
* Men with any family history of above mutation
* Family history of breast, prostate, or ovarian cancer in at least 2 individuals, or in 1 individual diagnosed before age 50
Exclusion Criteria:
* \* Anuria
* Prior diagnosis or treatment for PCa
* Failure to provide informed consent
* Life expectancy \< 5 yearsReferences
Publications (0)
Data not yet available
No reference posted for this study.