Germline genetic profiling for targeted prostate cancer screening and treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.