Prostate CancerNCT04705038
Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments
A study testing Patient Education in people with Prostate Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 30 Apr 2025
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of metastatic prostatic adenocarcinoma
- Receiving luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist therapy continuously for at least 1 year with anticipated lifelong therapy
- Able to complete written surveys in English
Who cannot join
- More than 2 prior systemic treatment regimens utilized in addition to castration.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
About this study
Official title: A Feasibility Study of Orchiectomy in Patients With Prostate Cancer on Chronic LHRH Agonist or Antagonist Therapy
The purpose of this study is to learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles).
- Conditions
- Prostate Cancer
- Being tested
- Patient Education
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationBehavioural
Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires. Receives: Behavioral: Patient Education |
| No Intervention | No intervention | Participants that decline the education session will continue with routine care of their cancer. They will also be asked to complete questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that undergo orchiectomy after receiving study education intervention
Measured: 1 year
Secondary outcomes (6)
Number of patients that agree to participate in an educational session on surgical orchiectomy
Measured: 1 year
Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.
Measured: 1 year
Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.
Measured: 1 year
Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.
Measured: 1 year
Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale.
Results of patient reported satisfaction regarding their decision to undergo orchiectomy will be reported based on responses to validated Decision Regret Scale questionnaire. Higher regret scores will be associated with dissatisfaction with the decision, lower regret scores will be associated with satisfaction regarding treatment decision.
Measured: 1 year
Comparison of costs of medical versus surgical castration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start18 Dec 2020
- Primary completion30 Apr 2025
- Study completion30 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 University of ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nabiel Mir, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705038
- Sponsor's protocol ID
- IRB20-0736
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Orchiectomy in Patients With Prostate Cancer on Chronic LHRH Agonist or Antagonist Therapy
- ClinicalTrials.gov ID
- NCT04705038
- Acronym / sponsor ID
- IRB20-0736
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 12 Jan 2021 (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 learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: Patient EducationParticipants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires. |
| No Intervention | No intervention | –Participants that decline the education session will continue with routine care of their cancer. They will also be asked to complete questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of metastatic prostatic adenocarcinoma
- Receiving luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist therapy continuously for at least 1 year with anticipated lifelong therapy
- Able to complete written surveys in English
Key exclusion criteria (1 listed)
- More than 2 prior systemic treatment regimens utilized in addition to castration.
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 |
|---|---|---|
| Patient EducationBrief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer. | Behavioural | Educational Intervention |
Primary outcome
Number of patients that undergo orchiectomy after receiving study education intervention
Time frame: 1 year
6 secondary outcomes
Number of patients that agree to participate in an educational session on surgical orchiectomy
Time frame: 1 year
Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.
Time frame: 1 year
Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.
Time frame: 1 year
Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.
Time frame: 1 year
Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale.
Time frame: 1 year
Comparison of costs of medical versus surgical castration
Time frame: 1 year
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 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Nabiel Mir, MD study chair
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education in people with Prostate Cancer, run by University of Chicago 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 3 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: finished, as of the sponsor's last update on 27 Mar 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 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?
Number of patients that undergo orchiectomy after receiving study education intervention (time frame: 1 year). 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 Mar 2026.