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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Bicalutamide; Drug: Dutasteride; Drug: Finasteride; Radiation: Radiation

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oral Androgen Therapy; Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

Drug: 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.; Other Names: Casodex; 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.; Other Names: Avodart; Jalyn; 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.; Other Names: Proscar; Propecia; Radiation: Radiation; 7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Free From Biochemical Failure	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.	4 years

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Stanley Liauw, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2010
• Primary Completion (Actual): May 1, 2020
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: April 25, 2011
• First Posted (Estimated): April 27, 2011

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Prostate cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Steroid Synthesis Inhibitors; Hormone Antagonists; Urological Agents; Androgen Antagonists; 5-alpha Reductase Inhibitors; Dutasteride; Bicalutamide; Finasteride
• Other Study ID Numbers: 10-625-A