Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Stage 1

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSt Vincent's Hospital, Sydney

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Semi-structured Interview

    Other intervention

    this 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

24 Participants
are divided into 1 treatment group
Group A: A qualitative approach with semi-structured interviews.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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St Vincent's Hospital, Sydney

Lead sponsor

University of Technology, Sydney

Collaborator