Germline genetic profiling for targeted prostate cancer screening and treatment
The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment
This study is testing if targeted prostate cancer screening can help men who are at higher genetic risk due to their family history or ethnicity find cancer earlier and improve their treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | Male |
| Sponsor | Institute of Cancer Research, United Kingdom Academic / other |
| Locations | 1 site (Sutton, Surrey) |
| Trial ID | NCT02543905 on ClinicalTrials.gov |
What this trial studies
The PROFILE study investigates the role of targeted prostate cancer screening in men at genetically higher risk due to ethnicity, family history, or genetic predisposition. It aims to estimate the incidence of prostate cancer and evaluate the sensitivity and specificity of PSA screening in these populations. The study will also identify biomarkers from biological samples and imaging technologies to correlate with genetic risk. By using an observational approach, it seeks to understand the relationship between genetic profiles and cancer incidence.
Who should consider this trial
Good fit: Ideal candidates include men with a family history of prostate cancer, men of black African or black African-Caribbean ancestry, or men with known genetic mutations that increase prostate cancer risk.
Not a fit: Patients without a family history of prostate cancer or those not belonging to high-risk ethnic groups may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance prostate cancer screening and treatment strategies for high-risk populations.
How similar studies have performed: Other studies have shown promise in using genetic profiling for cancer screening, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Either: 1. Men of any ethnicity with a positive family history of PrCa defined as: * Men with a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at \<70 years * Men with two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at \<70 years * Men with three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age Or 2. Men of black African or black African-Caribbean ancestry defined as: Both parents and all 4 grandparents being of either black African or black African-Caribbean ancestry. Or 3. Men of any ethnicity with a genetic predisposition to having prostate cancer e.g., being known to have inherited a gene mutation that increases risk of prostate cancer (e.g. BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2 and other DNA repair gene mutations as listed in the study protocol); and/or being known to have a high polygenic risk score (PRS) (defined as being in the top tenth percentile prior to enrolment). * Age 40- 69 years * WHO performance status 0-2 * Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow up schedule. Exclusion Criteria: * Previous cancer with a life expectancy of less than five years. * Previous PrCa * Negative biopsy within one year before recruitment * Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular/respiratory disease, immunosuppressive medication or splenectomy) * Men with body mass index (BMI) 40 and above. * Men with BMI 35 and above plus other co-morbidities. * Contraindications to having an MRI (non-MRI compliant pacemakers, aneurysm clips, metallic cardiac valve/stent, Ventriculo-Peritoneal (VP) shunt, cochlear implant, neurotransmitter, metallic foreign bodies in eye(s), other metalwork, claustrophobia) * Any significant psychological conditions that may be worsened or exacerbated by participation in the study
Where this trial is running
Sutton, Surrey
- Institute of Cancer Research and Royal Marsden Hospital — Sutton, Surrey, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Rosalind A Eeles — Institute of Cancer Research, United Kingdom
- Study coordinator: Elizabeth K Bancroft, PhD
- Email: elizabeth.bancroft@icr.ac.uk
- Phone: 44 207 808 2136
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.