Precision Medicine in the Prostate Cancer Care Pathway

Recruiting

• Conditions: Prostate Cancer; Genetic Predisposition
• Interventions: Genetic: Prostate cancer risk gene panel

• Registration Number: NCT04763317
• Lead Sponsor: Institute of Cancer Research, United Kingdom

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-12-31
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 2000

Inclusion Criteria

Affected cohort:

1. Affected with PrCa < 70 years or

2. Affected with metastatic castration resistant PrCa (mCRPC) at any age or

3. Affected with PrCa and a family history defined as

   1. two or more cases in family with one case < 70
   2. three or more cases any age (FDR or SDR)

Unaffected cohort:

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UNAFFECTED	Prostate cancer risk gene panel	- 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)
AFFECTED	Prostate cancer risk gene panel	1. Affected with PrCa \< 70 years 2. Affected with metastatic castration resistant PrCa (mCRPC) at any age 3. Affected with PrCa and a family history defined as 1. two or more cases in family with one case \< 70 2. three or more cases any age (FDR or SDR)

Primary Outcome Measures

Name	Time	Method
Prevalence of genetic variation in affected men	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 Outcome Measures

Name	Time	Method
Prostate Cancer genetic variation on clinical outcome	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.
Prevalence of genetic variation in unaffected men	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.

Trial Locations

Locations (1)

Royal Marsden Hosital,; 🇬🇧 Sutton, England, United Kingdom