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
Results First Posted : October 28, 2021
Last Update Posted : October 28, 2021
|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 Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire [ Time Frame: Baseline, 6 months, and 24 months ]
Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here.
Scale scores could range from 0-100, with higher scores indicating better quality of life.
- Percentage of Participants Free From Biochemical Failure [ Time Frame: 4 years ]Increase in prostate-specific antigen (PSA) measured over time. Freedom from biochemical failure (FFBF) was defined from the time of enrollment until PSA failure occurs as defined by the Phoenix definition of a rise to 2 ng/mL above the nadir PSA value.
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|