Clinical trial · Observational
PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients
A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)
- 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 registry is for men who have prostate cancer and have had multigene panel hereditary testing. The registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. It will also gather data on the patient's experience with genetic testing, through a post-test survey to be completed 60-90days after results have been received and discussed with their provider.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Invitae multi-cancer gene panel | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Individuals who meet NCCN Testing Criteria
- interventionNames
- Diagnostic Test: Invitae multi-cancer gene panel
- label
- Individuals who do not meet NCCN Testing Criteria
- interventionNames
- Diagnostic Test: Invitae multi-cancer gene panel
Primary outcomes (1)
- measure
- Diagnostic yield of pathogenic and likely pathogenic genes in the patient population
- timeFrame
- to be assessed at baseline only
- description
- Identify the diagnostic yield of pathogenic/likely pathogenic variants in known cancer syndrome genes in patients with prostate cancer, using the Invitae 84 gene multi-cancer panel. These rates will be compared between the two cohorts.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Men ages 18-90 who have been prescribed genetic testing as part of their clinical care * Have prostate cancer at any stage, either actively under treatment or being followed who either: 1. meet NCCN criteria for testing or 2. do not meet NCCN criteria for testing * Patients who are naive to clinical genetic testing for BRCA1/BRCA2 (single gene panel testing) Exclusion Criteria: * Mental or cognitive impairment that interferes with ability to provide informed consent
References
Publications (0)
Data not yet available