Prostate CancerPMPRCNCT04763317
Precision Medicine in the Prostate Cancer Care Pathway
An observational study of Prostate Cancer and Genetic Predisposition, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Prostate Cancer, Genetic Predisposition
- What is being tested?
- Prostate cancer risk gene panel
- How many people
- 3,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2019to Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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:
Show all 9Show fewer
- 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)
Who cannot join
- • WHO performance status 4
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hosital,
Sutton, England, SM2 5PT
Ros Eeles, 0208 7224483, prostate.research@rmh.nhs.uk
About this study
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
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.
- Conditions
- Prostate Cancer, Genetic Predisposition
- Being tested
- Prostate cancer risk gene panel
- Medical subject headings
- Prostatic Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate cancer risk gene panelGenetic
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
| Study group | Role | What they receive |
|---|---|---|
| AFFECTED | 1. Affected with PrCa <60 years
2. Affected with metastatic castration resistant PrCa (mCRPC) or aggressive PrCa (Gleason 4+4 or higher <70 years
3. Affected with PrCa and a family history defined as three or more cases any age (FDR or SDR) Receives: Genetic: Prostate cancer risk gene panel | |
| UNAFFECTED (Cohort now closed, recruitment complete) | - 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) Receives: Genetic: Prostate cancer risk gene panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start14 Feb 2019
- Primary completion31 Dec 2029 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763317
- Sponsor's protocol ID
- CCR4948
- Acronym
- PMPRC
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2020
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04763317
- Acronym / sponsor ID
- PMPRC / CCR4948
- Conditions
- Prostate Cancer, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFFECTED | – | Genetic: Prostate cancer risk gene panel1. Affected with PrCa <60 years 2. Affected with metastatic castration resistant PrCa (mCRPC) or aggressive PrCa (Gleason 4+4 or higher <70 years 3. Affected with PrCa and a family history defined as three or more cases any age (FDR or SDR) |
| UNAFFECTED (Cohort now closed, recruitment complete) | – | Genetic: Prostate cancer risk gene panel- 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) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- 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)
- FDR diagnosed < 70
Key exclusion criteria (1 listed)
- • WHO performance status 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate cancer risk gene panelA 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 | Genetic | AFFECTED, UNAFFECTED (Cohort now closed, recruitment complete) |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Genetic Predisposition, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of genetic variation in affected men (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.