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NCT Number: NCT04763317

Precision Medicine in the Prostate Cancer Care Pathway

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.

Recruiting

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Key information

Conditions

Prostate Cancer Disease Attributes Disease Susceptibility Genetic Predisposition Genetic Predisposition to Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Royal Marsden Hosital,

Sutton, England, SM2 5PT, United Kingdom

Location status: Recruiting

Location contact

Ros Eeles

CONTACT

[email protected]

0208 7224483

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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)

Exclusion criteria

  • • WHO performance status 4

Treatment and study plan

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

Primary outcomes

  1. Prevalence of genetic variation in affected men

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Prevalence of genetic variation in unaffected men

    Time frame: Through study completion, an average of 1 year

    To determine the prevalence of prostate cancer specific genetic variation in unaffected men with a strong family history of prostate cancer compared with controls.

  2. Prostate Cancer genetic variation on clinical outcome

    Time frame: Through study completion, an average of 1 year

    To determine how prostate cancer specific genetic variation influences clinical outcome in 'high-risk' vs 'low risk' groups.

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Royal Marsden NHS Foundation Trust

Registry information

Official study title

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

Acronym: PMPRC

Important dates

Study start
2019
Primary completion
2029
Study completion
2034
First posted
Feb 21, 2021
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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