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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients that undergo orchiectomy after receiving study education intervention
Secondary outcome measures
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
+3 moreTrial 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
~2680
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,677 Total Patients Enrolled
20 Trials studying Prostate Cancer
8,183 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been recruited to participate in this experiment?
"Affirmative. Per the records available on clinicaltrials.gov, this medical research project is actively recruiting volunteers; it was launched on December 18th 2020 and last updated February 8th 2022. A total of 100 participants need to be enrolled from a single centre."
Answered by AI
Are any fresh enrollees being accepted in this clinical trial?
"Affirmative. Clinicaltrials.gov verifies that this medical experiment, which was established on December 18th 2020, is currently enrolling volunteers. 100 participants are needed to be recruited from a single location."
Answered by AI
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