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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01342367
First received: April 15, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: Bicalutamide
Drug: Dutasteride
Drug: Finasteride
Radiation: Radiation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Health-related quality of life will be summarized using a score reflecting patient reported symptoms in sexual, hormone/vitality, fatigue, and overall quality of life.


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Increase in prostate specific antigen (PSA)measured over time.


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • Propecia
  • Proscar
Radiation: Radiation
7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342367

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Kimberly Janko, RN, BSN    773-702-2856    kjanko@radonc.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Stanley Liauw, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01342367     History of Changes
Other Study ID Numbers: 10-625-A
Study First Received: April 15, 2011
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Prostate cancer
Quality of Life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Finasteride
Dutasteride
Bicalutamide
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 01, 2014