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

NCT07552922 | Recruiting

• 1 other identifier: DINGO
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

gynaecomastia; prostate cancer; LHRH; testosterone; breast; estrogen

Outcome Measures

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.

  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.

  12 months

Study Arms (1)

A qualitative approach with semi-structured interviews.

EXPERIMENTAL

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

Interventions

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).

A qualitative approach with semi-structured interviews.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead
• University of Technology, Sydney: collaborator

Study Sites (1)

Kinghorn Cancer Centre

Sydney, New South Wales, 2010, Australia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Gynecomastia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: April 27, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-01

Locations

AU (1)