Prostate Cancer Clinical Trial
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
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 |
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