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External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, October 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00388804
  Purpose

Primary Objective:

  • To assess the possible improvement in prostate specific antigen (PSA) outcome of short course androgen suppression therapy in conjunction with dose-escalation intensity modulated radiation therapy (IMRT), 3D conformal radiation therapy (3D-CRT), or proton therapy over IMRT, 3D-CRT, or proton therapy alone in prostate cancer patients traditionally considered at intermediate risk for PSA failure following conventional local therapy. PSA failure will be the primary endpoint.

Secondary Objectives:

  • To assess local control, freedom from distant metastasis, and overall survival.
  • To study the impact of radiation therapy and/or hormone therapy on health-related quality of life measures using the Expanded Prostate Cancer Index Composite-Short Form 12-American Urological Association Symptom Index (EPIC-SF12-AUASI: http://roadrunner.cancer.med.umich.edu/epic/).
  • To assess prognostic value of pretreatment serum testosterone as well as the decrease in hemoglobin from neoadjuvant hormone therapy.
  • To assess prognostic value of pretreatment biomarkers on subsequent post-treatment clinical outcomes.

Condition Intervention Phase
Prostate Cancer
Procedure: Radiation Therapy
Drug: Bicalutamide
Drug: Leuprolide
Drug: Goserelin
Drug: Flutamide
Behavioral: Questionnaire
Phase III

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Goserelin Leuprolide acetate Leuprolide Flutamide Bicalutamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Randomized Trial of External Beam Radiation With or Without Short-Course Hormonal Therapy in Intermediate Risk Prostate Cancer Patients

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To look at the medical benefit of adding hormone therapy to high-dose radiation therapy, compared to giving high-dose radiation therapy alone, in the treatment of prostate cancer. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: February 2005
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Radiation Therapy
Procedure: Radiation Therapy
Radiation treatment given over about 8 1/2 weeks.
Behavioral: Questionnaire
Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.
2: Active Comparator
Radiation Therapy + Hormone Therapy (Bicalutamide/Flutamide + Leuprolide or Goserelin)
Procedure: Radiation Therapy
Radiation treatment given over about 8 1/2 weeks.
Drug: Bicalutamide
50 mg By Mouth (PO) Daily
Drug: Leuprolide
22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month
Drug: Goserelin
10.8 mg Subcutaneously Every 3 Months or 3.6 mg Subcutaneously Every 1 Month
Drug: Flutamide
250 mg PO Three Times Daily On the First 21-30 Days. May be used instead of Bicalutamide.
Behavioral: Questionnaire
Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy proven prostate cancer within last 12 months. Pathology must be reviewed at M.D. Anderson Cancer Center (MDACC).
  2. 1992 American Joint Committee on Cancer (AJCC) clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 and PSA < 20 ng/mL (i.e. PSA 19.99 ng/mL or less)
  3. 1992 AJCC clinical stage T2b on physical exam with biopsy Gleason sum of 7 or less and/or PSA < 20 ng/ml
  4. 1992 AJCC clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7 or less and PSA > 10 but less than 20 ng/ml (i.e. 10.01-19.99 ng/mL). PSA used for protocol eligibility should be obtained within 30 days of protocol enrollment.
  5. No evidence of metastatic disease on bone scan within 3 months of study enrollment.
  6. No evidence of metastatic disease on pelvic computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months of study enrollment.
  7. Zubrod performance status < 2.
  8. Must be able to understand protocol and adhere to follow-up initially at 3 months post-radiation and then at 6 month intervals for first two years and annually thereafter.
  9. Patient must be able to undergo adequate daily trans-abdominal ultrasound localization (B.A.T.) or other image-guided localization of the prostate during radiation course.
  10. Patients will be allowed to participate in other protocols if they are eligible and the other protocols do not interfere with participation in this protocol.

Exclusion Criteria:

  1. Patients who do not meet the inclusion criteria. Specifically, patients with all the following features: clinical T1c-2a and Gleason sum of 6 and PSA </= 10 ng/ml. Patients with one or more of the following features: clinical T2c, or Gleason 8-10, or PSA > 20 ng/ml are not eligible.
  2. Prior androgen suppression therapy. (Prior finasteride and saw palmetto allowed but must be discontinued prior to enrollment. Biopsy and PSA must be documented prior to finasteride use.)
  3. Previous or concurrent malignancies other than basal or squamous cell skin cancers unless disease-free for 5 years or more.
  4. Prior pelvic radiation or chemotherapy. Patients who received chemotherapy for non-prostate cancer malignancies over 5 years prior will be eligible.
  5. Prior or planned radical prostate surgery.
  6. Patients with clinical evidence or biopsy-proven extracapsular extension, seminal vesicle involvement, or lymph node involvement will be excluded. Patients with radiographic evidence of nodal or bone metastasis will be excluded.
  7. Other histologies such as small cell carcinoma, sarcomatoid or ductal variants are not eligible.
  8. Patients with any Gleason grade 5 disease on biopsy will not be eligible.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388804

Contacts
Contact: Andrew K. Lee, MD 713-792-5906

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Andrew K. Lee, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Andrew K. Lee, MD U.T.M.D. Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Andrew K. Lee, MD/Associate Professor )
Study ID Numbers: 2003-0819
Study First Received: October 15, 2006
Last Updated: October 29, 2008
ClinicalTrials.gov Identifier: NCT00388804  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
External Beam Radiotherapy
Radiation Therapy
Hormone Therapy
Bicalutamide
Casodex
Leuprolide
Lupron
Goserelin
Zoladex
Flutamide
EBRT

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Goserelin
Bicalutamide
Urogenital Neoplasms
Flutamide
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on January 16, 2009