Precision Medicine in the Prostate Cancer Care Pathway (PMPRC)

Precision Medicine in the Prostate Cancer Care Pathway: an Evaluation of Integrating Germline Genetic Testing Into the Management of Men at Risk of / Living With Prostate Cancer

This study aims to evaluate the use of a prostate cancer specific predisposition genetic panel test in men with / at high risk of prostate cancer. The genetic test will analyse men's DNA samples for the presence of mutations in rare genes as well as common genetic variation to provide men with information about their risk of prostate cancer. This study will evaluate the clinical impact of the test on risk assessment and clinical management in terms of screening and treatment.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Genetic Predisposition
• Intervention / Treatment: Genetic: Prostate cancer risk gene panel

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Sutton, England, United Kingdom, SM2 5PT
      • Recruiting
      • Royal Marsden Hosital,
      • Contact: Ros Eeles; Phone Number: 0208 7224483; Email: prostate.research@rmh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

There are two pathways for men to be approached about this study; first eligible men will be identified and approached by their clinical team in Urology and Uro-Oncology clinics at the Royal Marsden. Second, men already under the care of the Oncogenetics Research team due to their family history of prostate cancer and who meet the eligibility criteria will be given information about the study as deemed appropriate by the research clinician who has been managing their care (Research Nurse or Clinical Research Fellow).

Description

Inclusion Criteria:

Affected cohort:

1. Affected with PrCa < 60 years or
2. Affected with metastatic castration resistant PrCa (mCRPC) at any age or Aggressive PrCa Gleason 4+4 or higher <70 years
3. Affected with family history defined as three or more cases any age (FDR or SDR)

Unaffected cohort: (This cohort is no longer recruiting, it has completed recruitment)

Aged >30 and with a family history defined as:

1. FDR diagnosed < 70
2. 2 or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed < 70 years
3. 3 or more cases at any age (on same side of family)

Exclusion Criteria:

• • WHO performance status 4

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AFFECTED; Affected with PrCa <60 years; Affected with metastatic castration resistant PrCa (mCRPC) or aggressive PrCa (Gleason 4+4 or higher <70 years; Affected with PrCa and a family history defined as three or more cases any age (FDR or SDR)	Genetic: Prostate cancer risk gene panel; A list of genes created by study experts, thought to increase the risk of prostate cancer from from review previous research, this list is regularly reviewed for accuracy
UNAFFECTED (Cohort now closed, recruitment complete); - Aged >30 and with a family history defined as:: FDR diagnosed < 70; 2 or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed < 70 years; 3 or more cases at any age (on same side of family)	Genetic: Prostate cancer risk gene panel; A list of genes created by study experts, thought to increase the risk of prostate cancer from from review previous research, this list is regularly reviewed for accuracy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of genetic variation in affected men	To determine the prevalence of prostate cancer (PrCa) specific genetic variation in men with: (a)young onset PrCa; (b) metastatic PrCa; (c) men with PrCa and a family history of PrCa compared with controls.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of genetic variation in unaffected men	To determine the prevalence of prostate cancer specific genetic variation in unaffected men with a strong family history of prostate cancer compared with controls.	Through study completion, an average of 1 year
Prostate Cancer genetic variation on clinical outcome	To determine how prostate cancer specific genetic variation influences clinical outcome in 'high-risk' vs 'low risk' groups.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Collaborators: Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Disease Susceptibility; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Genetic Predisposition to Disease
• Other Study ID Numbers: CCR4948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No