Precision Medicine in the Prostate Cancer Care Pathway (PMPRC)

Institute of Cancer Research, United Kingdom

Status: Enrolling

Conditions: Genetic Predisposition; Prostate Cancer

Treatments: Genetic: Prostate cancer risk gene panel

Study type: Observational

Funder types: Other

Identifiers

NCT04763317

CCR4948

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 2 patient groups

AFFECTED

Description:

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)

Treatment:

Genetic: Prostate cancer risk gene panel

UNAFFECTED (Cohort now closed, recruitment complete)

Description:

\- 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)

Treatment:

Genetic: Prostate cancer risk gene panel