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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705038
• Other study ID #: IRB20-0736
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: University of Chicago
• Contact: Personalized Cancer Care Consortium
• Phone: 773.702.1220
• Email: PhaseIICRA[@]medicine.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Patient Education
Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.

Locations

Country	Name	City	State
United States	University of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients that undergo orchiectomy after receiving study education intervention		1 year
Secondary	Number of patients that agree to participate in an educational session on surgical orchiectomy		1 year
Secondary	Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.		1 year
Secondary	Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.		1 year
Secondary	Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.		1 year
Secondary	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.	1 year
Secondary	Comparison of costs of medical versus surgical castration		1 year