RecruitingNCT02543905

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


Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

1,600 participants

Start Date

Mar 9, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking men at higher-than-average risk of prostate cancer — due to family history, ethnic background, or known genetic mutations — to evaluate whether regular prostate cancer screening and early detection improves outcomes. **You may be eligible if...** - You are a man aged 40 to 69 years - You have a close family member (father, brother, or through a female relative) diagnosed with prostate cancer, especially before age 70 - You are of Black African or Black African-Caribbean descent (with all four grandparents of that heritage) - You carry a known genetic mutation that raises prostate cancer risk (such as BRCA1, BRCA2, ATM, or similar DNA repair gene mutations) or have a high polygenic risk score - You are in reasonably good general health **You may NOT be eligible if...** - You have previously been diagnosed with prostate cancer - You had a negative prostate biopsy within the last year - You have had another cancer with less than 5 years' life expectancy - You take blood-thinning medications (such as warfarin or novel anticoagulants) or have poorly controlled diabetes or heart/lung disease that makes a biopsy too risky - You have a BMI of 40 or above (or 35+ with other serious health conditions) - You have metal implants, a pacemaker, or severe claustrophobia preventing an MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREProstate MRI and Biopsy

All men will be offered a MRI and prostate biopsy and they can either opt to undergo these procedures at baseline irrespective of PSA level at baseline or they can undergo PSA-only screening until clinically indicated based on an age-defined PSA threshold, at which point, they will undergo prostate MRI and biopsy once their PSA reaches the threshold.


Locations(1)

Institute of Cancer Research and Royal Marsden Hospital

Sutton, Surrey, United Kingdom

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NCT02543905


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