Precision Medicine in the Prostate Cancer Care Pathway

NCT ID: NCT04763317

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-14

Study Completion Date

2034-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Genetic Predisposition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

Prostate cancer risk gene panel

Intervention Type 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

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)

Prostate cancer risk gene panel

Intervention Type 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

Interventions

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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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Marsden Hosital,

Sutton, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Ros Eeles

Role: primary

0208 7224483

Other Identifiers

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CCR4948

Identifier Type: -

Identifier Source: org_study_id