Evaluating a genetic test for prostate cancer risk
Precision Medicine in the Prostate Cancer Care Pathway: an Evaluation of Integrating Germline Genetic Testing Into the Management of Men at Risk of / Living With Prostate Cancer
Institute of Cancer Research, United Kingdom · NCT04763317
This study is testing a genetic test to see if it can help men at high risk for prostate cancer understand their risk better and make informed decisions about screening and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | Male |
| Sponsor | Institute of Cancer Research, United Kingdom (other) |
| Locations | 1 site (Sutton, England) |
| Trial ID | NCT04763317 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on assessing the effectiveness of a prostate cancer-specific genetic panel test in men who are at high risk for developing prostate cancer. By analyzing DNA samples, the study aims to identify mutations in rare genes and common genetic variations that may indicate an increased risk of prostate cancer. The findings will help evaluate how this genetic information impacts risk assessment and clinical management, including screening and treatment decisions for prostate cancer.
Who should consider this trial
Good fit: Ideal candidates include men under 70 with prostate cancer, those with metastatic castration-resistant prostate cancer, or individuals with a significant family history of prostate cancer.
Not a fit: Patients with a WHO performance status of 4 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide personalized risk assessments for prostate cancer, leading to better screening and treatment strategies.
How similar studies have performed: Other studies have shown promise in using genetic testing for cancer risk assessment, indicating that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Affected cohort: 1. Affected with PrCa \< 60 years or 2. Affected with metastatic castration resistant PrCa (mCRPC) at any age or Aggressive PrCa Gleason 4+4 or higher \<70 years 3. Affected with family history defined as three or more cases any age (FDR or SDR) Unaffected cohort: (This cohort is no longer recruiting, it has completed recruitment) Aged \>30 and with a family history defined as: 1. FDR diagnosed \< 70 2. 2 or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed \< 70 years 3. 3 or more cases at any age (on same side of family) Exclusion Criteria: * • WHO performance status 4
Where this trial is running
Sutton, England
- Royal Marsden Hosital, — Sutton, England, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Genetic Predisposition