External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00388804
First received: October 15, 2006
Last updated: June 29, 2012
Last verified: June 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of External Beam Radiation With or Without Short-Course Hormonal Therapy in Intermediate Risk Prostate Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Prostate Specific Antigen (PSA) Failures [ Time Frame: 3 months up to 2 years ] [ Designated as safety issue: No ]
    Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.


Enrollment: 39
Study Start Date: February 2005
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RT Group 1
Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
Procedure: Radiation Therapy
Radiation treatment given over about 8 1/2 weeks; 42 treatments, 5 days per week with 2 days rest in between.
Other Names:
  • RT
  • XRT
Behavioral: Questionnaire
Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.
Other Name: Survey
Active Comparator: RT Group 2 + Hormone Therapy
Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
Procedure: Radiation Therapy
Radiation treatment given over about 8 1/2 weeks; 42 treatments, 5 days per week with 2 days rest in between.
Other Names:
  • RT
  • XRT
Drug: Bicalutamide
50 mg By Mouth (PO) Daily
Other Name: Casodex
Drug: Leuprolide
22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month
Other Name: Lupron
Drug: Goserelin
10.8 mg Subcutaneously Every 3 Months or 3.6 mg Subcutaneously Every 1 Month
Other Name: Zoladex
Drug: Flutamide
250 mg by mouth three times daily on 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.
Other Name: Survey

  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 Prostate-Specific Antigen (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
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: NCT00388804

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00388804     History of Changes
Other Study ID Numbers: 2003-0819
Study First Received: October 15, 2006
Results First Received: June 29, 2012
Last Updated: June 29, 2012
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Goserelin
Flutamide
Bicalutamide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014