Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

All Drugs and Chemicals

Antineoplastic Agents

Urological Agents

Androgens

Hormones

Bicalutamide

Finasteride

Dutasteride

Androgen Antagonists

Hormone Antagonists

5-alpha Reductase Inhibitors

Enzyme Inhibitors

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.

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.

Radiation

Stanley Liauw, MD

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.

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

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

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.

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.

University of Chicago

the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks

SOC Cohort

Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks

Oral ADT Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

African American

White

Asian

Hispanic

Race/Ethnicity, Customized

United States

Region of Enrollment

Prostate-Specific Antigen (PSA)

The Adult Comorbidity Evaluation 27 (ACE-27) is a validated comorbidity instrument that provides a score (0-3; 1=mild, 2=moderate, 3=severe) based on the number and severity of medical comorbidities.

Adult Comorbidity Evaluation

Dr. Stanley Liauw

Baseline

6 month

24 month

the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks

Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks

Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire

Percentage of Participants Free From Biochemical Failure

Overall Study

Spots Global Cancer Trial Database for Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial