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

March 25, 2026 updated by: University of Chicago

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago Medicine Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational Intervention
Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires.
Behavioral: Patient Education
Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients that undergo orchiectomy after receiving study education intervention
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Study Chair: Nabiel Mir, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB20-0736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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