Precision Medicine in the Prostate Cancer Care Pathway
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age30-70
SponsorInstitute of Cancer Research, United Kingdom
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
FDR diagnosed < 70
Disqualifiers
• WHO performance status 4
Trial population
There are two pathways for men to be approached about this study; first eligible men will be identified and approached by their clinical team in Urology and Uro-Oncology clinics at the Royal Marsden. Second, men already under the care of the Oncogenetics Research team due to their family history of prostate cancer and who meet the eligibility criteria will be given information about the study as deemed appropriate by the research clinician who has been managing their care (Research Nurse or Clinical Research Fellow).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Prostate cancer risk gene panel
GeneticA 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
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: AFFECTED1 intervention
Group B: UNAFFECTED (Cohort now closed, recruitment complete)1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
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.
Time frame
Through study completion, an average of 1 year2
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.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Cancer Research, United Kingdom
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov