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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
More than 2 prior systemic treatment regimens utilized in addition to castration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will help to assess how an educational intervention on orchiectomy affects the number of patients willing to have the surgery.
Who is the study for?
This trial is for men with advanced prostate cancer who have been on hormone therapy for at least a year and expect to continue it. They must be able to fill out surveys in English. Men who've had more than two types of systemic treatments besides castration can't join.
What is being tested?
The study is looking into the effects of educating patients about orchiectomy, which is surgery to remove the testicles, as an alternative to ongoing medical hormone-blocking treatments for prostate cancer.
What are the potential side effects?
Since this trial focuses on education rather than medication or surgical intervention, there are no direct side effects from the educational material itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with advanced prostate cancer.
Select...
I have been on hormone therapy for over a year and expect to continue.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had more than two treatments for my cancer, in addition to hormone therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Educational InterventionExperimental Treatment1 Intervention
Participants in this arm undergo a short educational session about orchiectomy. They will also be asked to complete questionnaires.
Group II: No InterventionActive Control1 Intervention
Participants that decline the education session will continue with routine care of their cancer.
They will also be asked to complete questionnaires.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Education
2018
N/A
~2840
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,683 Total Patients Enrolled
22 Trials studying Prostate Cancer
8,297 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with advanced prostate cancer.I have had more than two treatments for my cancer, in addition to hormone therapy.I have been on hormone therapy for over a year and expect to continue.
Research Study Groups:
This trial has the following groups:- Group 1: Educational Intervention
- Group 2: No Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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