Prostate CancerNCT06500741
Experiment to Assess Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Prostate Cancer Patients
An observational study of Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the United States (US), Germany, Spain, France, Italy, the United Kingdom (UK), South Korea… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 374 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2024to 2 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult prostate cancer patients and urologists or oncologists who have cared for at least ten non-metastatic hormone-sensitive prostate cancer (nmHSPC) patients in the past year.
Who may be able to join
- Physician inclusion criteria
- The physician is a certified urologist or oncologist. The final selection will be adjusted to local practice.
- The physician has cared for at least ten nmHSPC patients in the past year.
- The physician has experience prescribing NHT and ADT. Patient inclusion criteria
- The patient has nmHSPC after radiotheraphy (RT) and/or radical prostatectomy (RP), defined as an adult patient with nmPC who had RT and/or RP.
Who cannot join
- Physician exclusion criteria
- None Patient exclusion criteria
- The patient is castration resistant.
- The patient has metastatic PC.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discrete Choice Experiment to Assess the Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Patients With Prostate Cancer
The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the United States (US), Germany, Spain, France, Italy, the United Kingdom (UK), South Korea, Australia, and Brazil, using a discrete choice experiment (DCE).
Read the detailed description
The study will collect data from eligible patients (six total) and physicians (six total) from one-on-one qualitative interviews and eligible patients from online surveys. Approximately 330 patients with PC will be recruited to complete the online DCE survey.
- Conditions
- Prostate Cancer
- Being tested
- No Intervention
- Keywords
- Prostate Cancer, Novel hormonal therapy, Androgen-deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No investigational drug will be administered to participants in this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants will include urologists or oncologists for the physician interviews and prostate cancer patients for the patient interviews and surveys. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Preference weights for different treatment attributes
Preference data will be collected via online survey questionnaires designed using DCE method.
Measured: Up to 1 day
Patients' Overall Preference for a specific treatment profile (NHT +/- ADT or ADT monotherapy)
Preference data will be collected via online survey questionnaires designed using DCE method.
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start22 Nov 2024
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500741
- Sponsor's protocol ID
- 9785-MA-3547
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discrete Choice Experiment to Assess the Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06500741
- Acronym / sponsor ID
- 9785-MA-3547
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Novel hormonal therapy, Androgen-deprivation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 15 Jul 2024 (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.
The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the United States (US), Germany, Spain, France, Italy, the United Kingdom (UK), South Korea, Australia, and Brazil, using a discrete choice experiment (DCE).
Detailed description
The study will collect data from eligible patients (six total) and physicians (six total) from one-on-one qualitative interviews and eligible patients from online surveys. Approximately 330 patients with PC will be recruited to complete the online DCE survey.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: No InterventionParticipants will include urologists or oncologists for the physician interviews and prostate cancer patients for the patient interviews and surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult prostate cancer patients and urologists or oncologists who have cared for at least ten non-metastatic hormone-sensitive prostate cancer (nmHSPC) patients in the past year.
Key inclusion criteria (5 listed)
- Physician inclusion criteria
- The physician is a certified urologist or oncologist. The final selection will be adjusted to local practice.
- The physician has cared for at least ten nmHSPC patients in the past year.
- The physician has experience prescribing NHT and ADT. Patient inclusion criteria
- The patient has nmHSPC after radiotheraphy (RT) and/or radical prostatectomy (RP), defined as an adult patient with nmPC who had RT and/or RP.
Key exclusion criteria (4 listed)
- Physician exclusion criteria
- None Patient exclusion criteria
- The patient is castration resistant.
- The patient has metastatic PC.
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 |
|---|---|---|
| No InterventionNo investigational drug will be administered to participants in this study. | Other | Participants |
Primary outcome
Patients' Preference weights for different treatment attributes
Time frame: Up to 1 day
Preference data will be collected via online survey questionnaires designed using DCE method.
Patients' Overall Preference for a specific treatment profile (NHT +/- ADT or ADT monotherapy)
Time frame: Up to 1 day
Preference data will be collected via online survey questionnaires designed using DCE method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 6 May 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' Preference weights for different treatment attributes (time frame: Up to 1 day). The study lists 2 primary outcomes in all. 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 6 May 2025.