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Clinical Trials/NCT07741929
NCT07741929RecruitingNot Applicable

Exploring the Patient and Provider Perspectives on the Utility of Genetic Risk Profiling for Prostate Cancer in Routine Clinical Practice

Royal Marsden NHS Foundation Trust1 site in 1 country40 target enrollmentStarted: May 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Data pertaining to the experiences and perspectives of healthcare providers and patients regarding the clinical utility of genetic risk profiling in routine clinical practice, using a qualitative (interview) thematic analysis approach.

Study Overview

Brief Summary

A qualitative interview study exploring the patient and provider perspectives on the clinical utility of genetic risk profiling in routine clinical practice. The findings from the study may contribute towards future research and informing clinical practice.

Detailed Description

Prostate cancer is the most prevalent cancer in men in the UK, however there are currently no formalised prostate cancer screening and risk management guidelines. Prostate cancer has a large heritable/genetic component and the combination of genetic alterations that a person inherits has a large influence on their risk. Genetic risk profiling can provide information on whether a person has a higher, average or lower genetic risk to develop prostate cancer. This can help to guide screening and management advice, with people at higher risk benefitting from increased surveillance and interventions, while sparing those at lower risk from unnecessary interventions. It can also provide guidance on potential treatments, prevention and reproductive risks and options. This can tailor and personalise healthcare for patients based on their risk, while also providing economic benefits to the healthcare system. Despite the benefits of genetic risk profiling, there are current concerns pertaining to the readiness for it's implementation into routine clinical practice given the lack of current risk management guidelines and uncertainty pertaining to actionability of results. Further research is essential to inform clinical practice.

This study will explore the perspectives of all stakeholders involved in the testing process, namely patients and healthcare providers who respectively receive and deliver genetic risk profiling results, to explore their viewpoints on the utility of genetic risk profiling in routine clinical practice. The research aims to explore current benefits, limitations, concerns and needs pertaining to genetic risk profiling which may contribute towards future research and clinical practice. Patients and providers who have received or delivered these results will be invited to participate in a once-off interview either at the Royal Marsden Hospital in Chelsea or Sutton or via video/telephone consultation. The research will be funded by the Royal Marsden Cancer Charity over 2 years.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Individuals assigned male at birth who are aged 18 and over and who have capacity to consent
  • Patients who have undergone genetic risk profiling for prostate cancer and have received their results
  • Individuals from diverse backgrounds (age, ethnicity, risk status, etc)
  • Healthcare providers who have delivered a genetic risk profiling result for prostate cancer

Exclusion Criteria

  • Individuals who lack capacity to consent
  • Individuals deemed unsuitable to recruit based on their poor performance status or current medical condition

Outcomes

Primary Outcomes

Data pertaining to the experiences and perspectives of healthcare providers and patients regarding the clinical utility of genetic risk profiling in routine clinical practice, using a qualitative (interview) thematic analysis approach.

Time Frame: January 2026 to August 2027

The study findings will provide data pertaining to the current experiences, perspectives, benefits, limitations and challenges patients and providers encounter when receiving and delivering genetic risk profiling results. The findings can help to highlight areas of concern which need to be addressed, improved and/or implemented prior to clinical implementation of genetic risk profiling into routine clinical care. The findings can also identify the educational, clinical and/or support needs and may also highlight aspects of clinical care which need to be improved or established (e.g. screening guidelines, resources, upskilled workforce) prior to the integration of genetic risk profiling into routine clinical practice. This will ensure that genetic risk profiling is relevant and feasible in terms of improving the clinical care and health seeking behaviours of patients.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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