Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations

NCT02705846 | Recruiting

• 2 other identifiers: 14/LO/0072CCR 4059
• Study Type: observational
• Target: 4,260
• Locations: 1 country
• Sites: 1

Brief Summary

GENPROS aims to analyse the outcomes of patients with rare gene mutations in the cancer predisposition genes, BRCA1, BRCA2, HOXB13, and Lynch Syndrome, after a diagnosis of and treatment for prostate cancer (PCa). The study includes a cohort of gene mutation carriers with PCa matched with a control group of men with PCa who are known not to carry a mutation in the same gene. Clinical data regarding treatment and patient outcome will be collected retrospectively and prospectively. Archived tumour samples will also be collected for tumour profiling. A blood or saliva sample will be taken, if the participant consents to this part of the study, for genetic profiling to investigate any association of other inherited factors with PCa outcomes. Information obtained from this study will be of critical importance to support clinical trials investigating the most appropriate management of PCa in this group of patients at increased risk of prostate cancer.

Conditions

Prostate Cancer

Keywords

BRCA1; BRCA2; Lynch Syndrome; Genetic predisposition to Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Cause Specific Survival (CSS) will be measured in men with prostate cancer who carry a rare germline mutation and compared to CSS in non-carriers

  Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up

  60 months

Secondary Outcomes (3)

• Biochemical progression free survival (bPFS) will be measured and compared between mutation carriers and non-carriers.

  60 months

• Metastasis free survival (MFS) after radical treatment will be measured and compared between mutation carriers and non-carriers.

  60 months

• Overall survival will be measured and compared between mutation carriers and non-carriers.

  60 months

Study Arms (2)

Mutation carriers with Prostate cancer

Men with prostate cancer and a known pathogenic germline mutation in: 1. the BRCA1 or BRCA2 gene 2. the HOXB13 gene 3. The MSH2 gene 4. All other Lynch Syndrome genes (MLH1, MSH6, PMS2, EPCAM) 5. The ATM gene 6. Other PCa predisposition genes

Other: Observation of treatment outcomes via Questionnaire

Mutation non carriers

Men with prostate cancer who have tested negative for a mutation in one of the following genes: 1. the BRCA1 or BRCA2 gene 2. the HOXB13 gene 3. The MSH2 gene 4. All other Lynch Syndrome genes (MLH1, MSH6, PMS2, EPCAM) 5. The ATM gene 6. Other PCa predisposition genes

Other: Observation of treatment outcomes via Questionnaire

Interventions

Observation of treatment outcomes via Questionnaire OTHER

Collection of treatment data from participants

Mutation carriers with Prostate cancer; Mutation non carriers

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes a cohort of rare gene mutation carriers with PCa and a control group formed of PCa patients known not to carry mutations in the same genes for comparison.

You may qualify if:

• Men diagnosed with PCa are eligible if:
• known carriers of germline mutations associated with PCa risk OR
• known non-carriers of mutations in the genes above

You may not qualify if:

• patients under 18 years of age
• patients who are unable to give informed consent
• patients who cannot be traced (\<6 months follow-up) or whose clinical data are not available
• patients whose genetic status is unknown

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

Institute of Cancer Research and Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva or blood samples will be collected from participants to analyse their DNA and look at genetic modifiers of prostate cancer. Tumour blocks will also be collected from patients where available.

MeSH Terms

Conditions

Prostatic Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rosalind A Eeles, PhD

  Institute of Cancer Research, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth C Page, MSc

CONTACT

44 208 722 4483; elizabeth.page@icr.ac.uk

Elizabeth Bancroft, PhD

CONTACT

44 208 722 4483; elizabeth.bancroft@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 11, 2016
• Study Start: September 1, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)