Study Summary
This trial will help to assess how an educational intervention on orchiectomy affects the number of patients willing to have the surgery.
Eligible Conditions
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 1 year
1 year
Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.
Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.
Comparison of costs of medical versus surgical castration
Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.
Number of patients that agree to participate in an educational session on surgical orchiectomy
Number of patients that undergo orchiectomy after receiving study education intervention
Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
No Intervention
1 of 2
Educational Intervention
1 of 2
Active Control
Experimental Treatment
100 Total Participants · 2 Treatment Groups
Primary Treatment: Patient Education · No Placebo Group · N/A
Educational Intervention
Behavioral
Experimental Group · 1 Intervention: Patient Education · Intervention Types: BehavioralNo InterventionNoIntervention Group · 1 Intervention: No Intervention · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Education
2018
N/A
~2680
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
University of ChicagoLead Sponsor
927 Previous Clinical Trials
753,912 Total Patients Enrolled
17 Trials studying Prostate Cancer
7,914 Patients Enrolled for Prostate Cancer
Walter Stadler, MDStudy ChairUniversity of Chicago
4 Previous Clinical Trials
108 Total Patients Enrolled
2 Trials studying Prostate Cancer
18 Patients Enrolled for Prostate Cancer
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a diagnosis of metastatic prostatic adenocarcinoma.
You are receiving LHRH agonist or LHRH antagonist therapy continuously for at least 1 year with anticipated lifelong therapy.
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Conditions
Cancer Related
Treatments