Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02705846
Recruitment Status : Recruiting
First Posted : March 11, 2016
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

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.

Condition or disease
Prostate Cancer

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1020 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutation in Cancer Predisposition Genes
Study Start Date : September 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
BRCA1 mutation carriers
Men with a known pathogenic germline BRCA1 mutation
BRCA2 mutation carriers
Men with a known pathogenic germline BRCA2 mutation
BRCA1 controls
Men known not to carry a pathogenic germline BRCA1 mutation
BRCA2 controls
Men known not to carry a pathogenic germline BRCA2 mutation



Primary Outcome Measures :
  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 [ Time Frame: 60 months ]
    Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up


Secondary Outcome Measures :
  1. Biochemical progression free survival (bPFS) will be measured and compared between mutation carriers and non-carriers. [ Time Frame: 60 months ]
    Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up

  2. Metastasis free survival (MFS) after radical treatment will be measured and compared between mutation carriers and non-carriers. [ Time Frame: 60 months ]
    Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up

  3. Overall survival will be measured and compared between mutation carriers and non-carriers. [ Time Frame: 60 months ]
    Survival will be calculated from the date of PCa diagnosis until date of death from any cause or censored at the last follow-up


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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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. In the first instance, carriers of mutations in the BRCA1 and BRCA2 genes will be recruited and as other gene variants are tested in the clinical and research settings, the investigators will expand the protocol to examine these associations also.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • patients who have been diagnosed with prostate cancer through the IMPACT study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705846


Contacts
Layout table for location contacts
Contact: Elizabeth C Page, MSc 44 208 722 4483 elizabeth.page@icr.ac.uk
Contact: Elizabeth Bancroft, PhD 44 208 722 4483 elizabeth.bancroft@rmh.nhs.uk

Locations
Layout table for location information
United Kingdom
Institute of Cancer Research and Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Rosalind A Eeles, FRCP FRFR    02086613642    rosalind.eeles@icr.ac.uk   
Principal Investigator: Rosalind A Eeles, FRCP FRCR         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Layout table for investigator information
Principal Investigator: Rosalind A Eeles, PhD Institute of Cancer Research, United Kingdom

Layout table for additonal information
Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02705846     History of Changes
Other Study ID Numbers: 14/LO/0072
CCR 4059 ( Other Grant/Funding Number: Committee for Clinical Research )
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data can be applied for via the Steering Commitee

Keywords provided by Institute of Cancer Research, United Kingdom:
BRCA1
BRCA2
Lynch Syndrome

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases