Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
NCT01342367 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74
Last updated 2025-06-10
Summary
The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care.
Conditions
Interventions
- DRUG
-
Bicalutamide
Bicalutamide 50 mg orally daily with either dutasteride or finasteride for 2 months. After two months of treatment bicalutamide with either dutasteride or finasteride will be taken along with radiation. After completion of radiation, bicalutamide will be stopped.
- DRUG
-
Dutasteride
Dutasteride 0.5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment dutasteride and bicalutamide will be taken along with radiation. After completion of radiation, dutasteride will be taken alone for two years.
- DRUG
-
Finasteride 5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment finasteride and bicalutamide will be taken along with radiation. After completion of radiation, finasteride will be taken alone for two years.
- RADIATION
-
Radiation
7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.
Sponsors & Collaborators
-
University of Chicago
lead OTHER
Principal Investigators
-
Stanley Liauw, MD · University of Chicago
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-17
- Primary Completion
- 2020-05-01
- Completion
- 2026-02-28
Countries
- United States
Study Locations
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