Precision Medicine in the Prostate Cancer Care Pathway (PMPRC)

April 6, 2023 updated by: Institute of Cancer Research, United Kingdom

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study 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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AFFECTED
  1. Affected with PrCa < 70 years
  2. Affected with metastatic castration resistant PrCa (mCRPC) at any age

  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)
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
UNAFFECTED

- 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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of genetic variation in affected men
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of genetic variation in unaffected men
Time Frame: Through study completion, an average of 1 year
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
Prostate Cancer genetic variation on clinical outcome
Time Frame: Through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2019

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR4948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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