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

NCT01342367 | Active Not Recruiting Results

• 1 other identifier: 10-625-A
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate cancer; Quality of Life

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 6 months, and 24 months

Secondary Outcomes (1)

• Percentage of Participants Free From Biochemical Failure

  4 years

Study Arms (1)

Oral Androgen Therapy

EXPERIMENTAL

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

Drug: Bicalutamide; Drug: Dutasteride; Drug: Finasteride; Radiation: Radiation

Interventions

Bicalutamide 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.

Also known as: Casodex

Oral Androgen Therapy

Dutasteride 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.

Also known as: Avodart, Jalyn

Oral Androgen Therapy

Finasteride 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.

Also known as: Propecia, Proscar

Oral Androgen Therapy

Radiation RADIATION

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

Oral Androgen Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Dutasteride; Finasteride; Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstenes; Androstanes; Physical Phenomena

Results Point of Contact

• Title: Dr. Stanley Liauw
• Organization: The University of Chicago

sliauw@radonc.uchicago.edu

7737026870

Study Officials

• Stanley Liauw, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 27, 2011
• Study Start: December 17, 2010
• Primary Completion: May 1, 2020
• Study Completion: February 1, 2026
• Last Updated: June 10, 2025
• Results First Posted: October 28, 2021

Record last verified: 2025-06

Locations

US (1)