Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01342367|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2011
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Bicalutamide Drug: Dutasteride Drug: Finasteride Radiation: Radiation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 17, 2010|
|Actual Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||February 2024|
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: Casodex
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.
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.
7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.
- Quality of Life [ Time Frame: 6 months ]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 ]Increase in prostate specific antigen (PSA)measured over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342367
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Stanley Liauw, MD||University of Chicago|