About this trial
This study aims to explore the perceptions of men with prostate cancer (PCa) and high-risk biochemical recurrence (BCR) regarding the risk of breast-related side effects, including gynaecomastia, from treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men with high-risk BCR PCa but no ADT+/-ARPI experience.
Men with ADT+/-ARPI experience who have experienced breast-related side effects from this treatment.
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Semi-structured Interview
Other interventionthis t study will use qualitative methods to explore men's views of gynaecomastia from high-risk BCR PCa treatments (Stage 1) to inform attributes and levels for a later DCE to examine patient treatment preferences (Stage 2).
Treatment groups
Trial outcomes
Primary outcomes
Number and content of themes and subthemes describing PCa patients' perceptions of the risk of breast-related side effects, including gynaecomastia, from high-risk BCR PCa treatment.
The outcome will be the set of themes and subthemes identified through qualitative analysis of semi-structured interviews. Interviews will be conducted with three groups: (1) men with high-risk BCR prostate cancer; (2) men with ADT ± ARPI experience; and (3) men who have experienced breast-related side effects from prostate cancer treatment.
Secondary outcomes
Number and content of discrete choice experiment (DCE) attributes and their levels, developed to assess the trade-offs patients are willing to make between breast-related side effects, other QoL impacts, and cancer control.
The outcome will be a finalised set of attributes and levels for a DCE. Attributes and levels will be generated through semi-structured qualitative interviews with patients, analysed iteratively across participant groups, and refined with input from an advisory panel. A 'generator developed' approach will then be used to design the final set of attributes and levels for inclusion in the DCE.
Sponsors and contacts
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St Vincent's Hospital, Sydney
Lead sponsor
University of Technology, Sydney
Collaborator