Precision Medicine in the Prostate Cancer Care Pathway

Prostate Cancer Clinical Trial

— PMPRC  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04763317
• Other study ID #: CCR4948
• Status: Recruiting
• Start date: February 14, 2019
• Est. completion date: December 2030

Study information

• Verified date: April 2024
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Genetic Predisposition
• Genetic Predisposition to Disease
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• 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

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hosital,	Sutton	England

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of genetic variation in unaffected men	To determine the prevalence of prostate cancer specific genetic variation in unaffected men with a strong family history of prostate cancer compared with controls.	Through study completion, an average of 1 year
Secondary	Prostate Cancer genetic variation on clinical outcome	To determine how prostate cancer specific genetic variation influences clinical outcome in 'high-risk' vs 'low risk' groups.	Through study completion, an average of 1 year