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

April 22, 2026 updated by: Anthony Joshua, FRACP, St Vincent's Hospital, Sydney

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A qualitative approach with semi-structured interviews.
Through purposive sampling, we plan to conduct interviews with men from two groups: those with high-risk BCR PCa but no ADT+/-ARPI experience, and men with ADT+/-ARPI experience who have experienced breast-related side effects from this treatment. To inform an understanding of how perception of breast-related symptoms might inform treatment preferences, it is important to understand perspectives regarding the hypothetical risk of side-effects as well as those based on actual experience.
Other: Semi-structured Interview
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Vincent's Hospital, Sydney

Collaborators

University of Technology, Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

September 21, 2025

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DINGO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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