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

Plain-language summary

This study investigates how germline (inherited) genetic profiling relates to targeted prostate cancer screening and treatment; participants undergo prostate MRI and biopsy. Men aged 40 to 69 with a family history of prostate cancer, of black African or African-Caribbean ancestry, or carrying a risk-increasing mutation in genes such as BRCA1, BRCA2, ATM, or PALB2 may take part. It is being carried out as a study with no assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Intervention

Prostate MRI and Biopsy

Start date

3/9/2015

Estimated completion

12/31/2026

Countries

United Kingdom

Related genes

Locations

• Sutton, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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