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NCT Number: NCT07552922

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

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.

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Key information

Conditions

Prostate Cancer (Adenocarcinoma) Adenocarcinoma Breast Diseases Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gynecomastia Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kinghorn Cancer Centre

Sydney, New South Wales, 2010, Australia

Location status: Recruiting

Location contact

Anthony M Joshua, MBBS PhD

CONTACT

[email protected]

+61293555655

About this study

This study will inform a set of 'attributes' and their levels that can be used in a later discrete choice experiment (DCE), for which separate ethical approval will be sought, to assess the trade-offs patients are willing to make between breast-related side effects, other quality of life (QOL) impacts and cancer control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Men receiving psychiatric care as a consequence of their prostate cancer diagnosis or treatment thereof.

Treatment and study plan

semi-structured interview

Other

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).

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.

    Time frame: 12 months

    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

  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.

    Time frame: 12 months

    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 collaborators

Lead sponsor

St Vincent's Hospital, Sydney

Other

Collaborators

  • University of Technology, Sydney

Registry information

Official study title

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

Acronym: DINGO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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