Trial Summary
What is the purpose of this trial?This trial is testing if taking hormone pills can improve the quality of life and survival rates for patients who need hormone-based treatment. The pills work by adjusting hormone levels in the body to help manage their condition.
Eligibility Criteria
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.Inclusion Criteria
Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%
One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA > 20 ng/ml, Clinical Stage T3a-T4
Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal
+17 more
Exclusion Criteria
Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer
+6 more
Participant Groups
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.
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)
Bicalutamide is already approved in European Union, United States, Japan, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Casodex for:
- Metastatic prostate cancer
- Locally advanced prostate cancer
🇺🇸 Approved in United States as Casodex for:
- Metastatic prostate cancer
🇯🇵 Approved in Japan as Casodex for:
- Metastatic prostate cancer
- Locally advanced prostate cancer
🇨🇦 Approved in Canada as Casodex for:
- Metastatic prostate cancer
- Locally advanced prostate cancer
🇦🇺 Approved in Australia as Casodex for:
- Metastatic prostate cancer
- Locally advanced prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor