Precision Medicine in the Prostate Cancer Care Pathway

NCT04763317 | Recruiting DMC

• 1 other identifier: CCR4948
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Genetic Predisposition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prevalence of genetic variation in unaffected men

  Through study completion, an average of 1 year

• Prostate Cancer genetic variation on clinical outcome

  Through study completion, an average of 1 year

Study Arms (2)

AFFECTED

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

Genetic: Prostate cancer risk gene panel

UNAFFECTED (Cohort now closed, recruitment complete)

\- 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)

Genetic: Prostate cancer risk gene panel

Interventions

Prostate cancer risk gene panel GENETIC

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

AFFECTED; UNAFFECTED (Cohort now closed, recruitment complete)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Affected cohort:
• Affected with PrCa \< 60 years or
• Affected with metastatic castration resistant PrCa (mCRPC) at any age or Aggressive PrCa Gleason 4+4 or higher \<70 years
• 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:
• FDR diagnosed \< 70
• or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed \< 70 years
• or more cases at any age (on same side of family)

You may not qualify if:

• WHO performance status 4

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (1)

Royal Marsden Hosital,

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood DNA or Saliva sample is collected from the participant for genetic analysis

MeSH Terms

Conditions

Prostatic Neoplasms; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: February 21, 2021
• Study Start: February 14, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 1, 2034
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)