Prostate Cancer (Adenocarcinoma)DINGONCT07552922
Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Stage 1
A study testing Semi-structured Interview in people with Prostate Cancer (Adenocarcinoma), run by St Vincent's Hospital, Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Semi-structured Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Men receiving psychiatric care as a consequence of their prostate cancer diagnosis or treatment thereof.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Kinghorn Cancer Centre
Sydney, New South Wales, 2010
Anthony M Joshua, MBBS PhD, +61293555655, svhs.cancerresearch@svha.org.au
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Semi-structured Interview
- Keywords
- gynaecomastia, prostate cancer, LHRH, testosterone, breast, estrogen
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Gynecomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured InterviewOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Semi-structured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Dec 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital, Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- University of Technology, Sydney
- Responsible party
- Principal investigator, Anthony Joshua, FRACP, St Vincent's Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552922
- Sponsor's protocol ID
- DINGO
- Acronym
- DINGO
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining INdividual Preferences for Gynecomastia avOidance (DINGO) - Qualitative Stage
- ClinicalTrials.gov ID
- NCT07552922
- Acronym / sponsor ID
- DINGO / DINGO
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- gynaecomastia, prostate cancer, LHRH, testosterone, breast, estrogen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- St Vincent's Hospital, SydneyUniversity, hospital or other
- Collaborators
- University of Technology, Sydney
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A qualitative approach with semi-structured interviews. | Experimental | Other: Semi-structured InterviewThrough 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Men receiving psychiatric care as a consequence of their prostate cancer diagnosis or treatment thereof.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured Interviewthis 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). | Other | A qualitative approach with semi-structured interviews. |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured Interview in people with Prostate Cancer (Adenocarcinoma), run by St Vincent's Hospital, Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.