Precision Medicine in the Prostate Cancer Care Pathway
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prostate cancer risk gene panel.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Genetic Predisposition. Basic parameters: 30 years — 70 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Prevalence of genetic variation in affected men [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (2)
- Prevalence of genetic variation in unaffected men [Time frame: Through study completion, an average of 1 year]
- Prostate Cancer genetic variation on clinical outcome [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
Affected cohort:
- Affected with PrCa < 60 years or
- Affected with metastatic castration resistant PrCa (mCRPC) at any age or Aggressive PrCa Gleason 4+4 or higher <70 years
- 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:
- FDR diagnosed < 70
- 2 or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed < 70 years
- 3 or more cases at any age (on same side of family)
Exclusion criteria
- • WHO performance status 4
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Royal Marsden Hosital, — Sutton
Identifiers
NCT: NCT04763317 · CCR4948