The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment

Launched by INSTITUTE OF CANCER RESEARCH, UNITED KINGDOM · Sep 4, 2015

Keywords

ClinConnect Summary

The PROFILE Study is looking into how genetic testing can help identify men at higher risk for prostate cancer. Prostate cancer is the most common cancer in men, and certain factors like family history and ethnicity can increase this risk. This study will focus on men between the ages of 40 and 69 who either have a family history of prostate cancer, are of black African or black African-Caribbean ancestry, or have a known genetic predisposition to prostate cancer. If eligible, you may participate in screenings like blood tests, MRIs, and biopsies to see if any genetic changes that increase prostate cancer risk are present in your DNA.

Participants in this study can expect to undergo various tests to assess their risk of prostate cancer. The goal is to understand how genetic profiling can assist in screening programs and potentially lead to earlier detection and treatment of prostate cancer in men who need it most. It’s important to note that the study has specific criteria for who can participate, including age and health conditions, so not everyone will qualify. If you think you might be eligible, this study could be an important step in understanding your prostate health.

Gender

MALE

Eligibility 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