Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities|
- Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]Health-related quality of life will be summarized using a score reflecting patient reported symptoms in sexual, hormone/vitality, fatigue, and overall quality of life.
- Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Increase in prostate specific antigen (PSA)measured over time.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||April 2019|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Oral Androgen Therapy
Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
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.
Other Name: CasodexDrug: 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.
Other Names:Drug: Finasteride
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.
Other Names:Radiation: Radiation
7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342367
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Kimberly Janko, RN, BSN 773-702-2856 firstname.lastname@example.org|
|Principal Investigator:||Stanley Liauw, MD||University of Chicago|