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Hormone Therapy
Hormone Therapy + Radiation for Prostate Cancer
N/A
Waitlist Available
Led By Stanley Liauw, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will compare quality of life and survival rates for patients receiving oral hormone therapy or standard of care.
Who is the study for?
Men aged 18+ with intermediate or high-risk prostate cancer who haven't had radical surgery, hormonal therapy, or certain other treatments for prostate cancer. They should have a life expectancy of at least 10 years and be able to give informed consent. Men with severe health issues like unstable angina, active infections needing IV antibiotics, liver problems, AIDS, or autoimmune diseases are excluded.Check my eligibility
What is being tested?
The trial is testing if oral hormone therapies (Bicalutamide, Dutasteride, Finasteride) plus radiation improve quality of life and survival rates compared to standard care in men with prostate cancer. It's looking at how well patients do on these drugs versus the usual treatment.See study design
What are the potential side effects?
Possible side effects from the hormone therapies may include breast tenderness/enlargement, hot flashes, reduced sex drive/erectile function; while radiation can cause fatigue, skin changes in treated area and urinary/bowel symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire
Secondary outcome measures
Percentage of Participants Free From Biochemical Failure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Oral Androgen TherapyExperimental Treatment4 Interventions
Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Finasteride
FDA approved
Radiation
2003
Completed Phase 2
~780
Bicalutamide
FDA approved
Dutasteride
FDA approved
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,012 Previous Clinical Trials
733,996 Total Patients Enrolled
21 Trials studying Prostate Cancer
8,266 Patients Enrolled for Prostate Cancer
Stanley Liauw, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Oral Androgen Therapy
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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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