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

NCT ID: NCT01342367

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-17
• Study Completion Date: 2026-02-28

Brief 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

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Androgen Therapy

Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

Group Type: EXPERIMENTAL

Bicalutamide

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: 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

Intervention Type: RADIATION

7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Radiation

7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.

Intervention Type: RADIATION

Other Intervention Names

Casodex; Avodart; Jalyn; Propecia; Proscar

Eligibility Criteria

Inclusion Criteria

• Age > or = 70 years and/or Charlson comorbidity index score > or = 2
• Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma
• Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%
• One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA > 20 ng/ml, Clinical Stage T3a-T4
• Clinically negative lymph nodes as established by imaging, nodal sampling, or dissection
• No evidence of bone metastases on bone scan
• History/physical examination via the Charlson Comorbidity Index within 60 days prior to registration
• Zubrod Performance Status 0-2
• Age > or = 18
• Baseline serum PSA within 60 days prior to registration
• Baseline serum testosterone obtained within 60 days prior to registration
• Study entry PSA and serum testosterone must not be obtained during the following time frames, 10-day period following prostate biopsy, following initiation of oral androgen manipulation, within 30 days after discontinuation of finasteride or dutasteride
• CBC/ differential obtained within 60 days prior to registration with adequate bone marrow function
• Patient must be able to provide study-specific informed consent prior to study entry
• Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal

Exclusion Criteria

• Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
• Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
• Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer
• Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
• Prior radiation, including brachytherapy, to the region of the prostate that would result in overlap of RT fields
• Active lupus or scleroderma
• Severe, active co-morbidity, including but not limited to,unstable angina within the last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Hepatic insufficiency with AST, ALT, or Bilirubin > 2 x upper limit of normal,clinical jaundice, and/or coagulation defects
• Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not required for entry into this protocol.Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanley Liauw, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

10-625-A

Identifier Type: -

Identifier Source: org_study_id