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OpenTrials
Completed

NCT Number: NCT04705038

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

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient education

Behavioral

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

Primary outcomes

  1. Number of patients that undergo orchiectomy after receiving study education intervention

    Time frame: 1 year

Secondary outcomes

  1. Number of patients that agree to participate in an educational session on surgical orchiectomy

    Time frame: 1 year

  2. Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.

    Time frame: 1 year

  3. Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.

    Time frame: 1 year

  4. Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.

    Time frame: 1 year

  5. 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.

  6. Comparison of costs of medical versus surgical castration

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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