Actively Recruiting
The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment
Led by Institute of Cancer Research, United Kingdom · Updated on 2025-07-25
1600
Participants Needed
1
Research Sites
616 weeks
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
R
Royal Marsden NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prostate cancer is now the most common cancer in men in the Western world. In the United Kingdom (UK), there were over 52,000 new cases diagnosed in 2016-2018 and a lifetime risk of 1 in 8. Prostate cancer (PrCa) can run in some families and research studies have identified several genetic changes in Caucasian populations that are thought to increase the risk of developing prostate cancer. Other studies have shown that men from certain ethnic groups also have a higher risk of prostate cancer, and this includes men of black African or black African-Caribbean ancestry. This study aims to look at men with a higher risk of prostate cancer based on their ethnicity, family history and/or genetic predisposition to see whether any of these genetic changes are present in their DNA (genetic material) and whether this could be a helpful screening tool in prostate cancer screening programmes. It is thought that many genetic changes are involved in the development of prostate cancer and research is being carried out worldwide to identify these genetic changes. Some of these changes may cause a very slight increase in prostate cancer risk while others may cause a much larger increase in risk of developing prostate cancer. The investigators will invite (i) men of any ethnicity with a family history of prostate cancer; (ii) men of black African or black African-Caribbean ancestry; and (iii) men of any ethnicity with a known genetic predisposition to having prostate cancer (e.g., being known to have inherited a gene mutation that increases risk of prostate and/or being known to be in the top tenth percentile of the polygenic risk score (high PRS score prior to enrolment) for targeted prostate screening (Prostate Specific Antigen (PSA) testing, MRI and a biopsy of the prostate gland) and genetic profiling. The outcome of these prostate cancer screening investigations will be compared with the genetic profiles of those taking part in the study in order to look for certain genetic changes in the gene code that are thought to increase prostate cancer risk. This research will help us to determine what the role of such genetic profiling is in a prostate cancer screening programme and if it helps identify men at high prostate cancer risk.
CONDITIONS
Official Title
The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 40 to 69 years
- Men of any ethnicity with a family history of prostate cancer defined as having one first-degree relative (or second-degree through female line) diagnosed before age 70, or two relatives on the same side of the family with at least one diagnosed before age 70, or three relatives diagnosed at any age
- Men of black African or black African-Caribbean ancestry with both parents and all four grandparents of that ancestry
- Men of any ethnicity with a genetic predisposition to prostate cancer such as inherited gene mutations (e.g., BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2) or a high polygenic risk score in the top tenth percentile prior to enrolment
- WHO performance status 0-2
- No psychological, familial, sociological, or geographical issues that would interfere with study compliance and follow-up
You will not qualify if you...
- Previous cancer with a life expectancy less than five years
- Previous prostate cancer diagnosis
- Negative prostate biopsy within one year before recruitment
- Co-morbidities that make prostate biopsy risky, including use of anticoagulants or antiplatelet medications, poorly controlled diabetes, cardiovascular or respiratory disease, immunosuppressive medication, or splenectomy
- Body mass index (BMI) of 40 or above
- BMI of 35 or above with other co-morbidities
- Contraindications to MRI such as non-MRI compatible pacemakers, aneurysm clips, metallic cardiac valves or stents, ventricular shunts, cochlear implants, metallic foreign bodies in eyes, claustrophobia
- Significant psychological conditions that could worsen or be exacerbated by study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Cancer Research and Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
E
Elizabeth K Bancroft, PhD
CONTACT
E
Eva McGrowder, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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