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Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments

A Feasibility Study of Orchiectomy in Patients With Prostate Cancer on Chronic LHRH Agonist or Antagonist Therapy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04705038
Enrollment
101
Registered
2021-01-12
Start date
2020-12-18
Completion date
2025-04-30
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief 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).

Interventions

BEHAVIORALPatient Education

Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* More than 2 prior systemic treatment regimens utilized in addition to castration.

Design outcomes

Primary

MeasureTime frame
Number of patients that undergo orchiectomy after receiving study education intervention1 year

Secondary

MeasureTime frameDescription
Number of patients that agree to participate in an educational session on surgical orchiectomy1 year
Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.1 year
Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.1 year
Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.1 year
Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale.1 yearResults 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.
Comparison of costs of medical versus surgical castration1 year

Countries

United States

Contacts

STUDY_CHAIRNabiel Mir, MD

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026