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

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ClinicalTrials.gov Identifier: NCT00388804
Recruitment Status : Terminated (Slow accrual.)
First Posted : October 17, 2006
Results First Posted : August 8, 2012
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Procedure: Radiation Therapy Drug: Bicalutamide Drug: Leuprolide Drug: Goserelin Drug: Flutamide Behavioral: Questionnaire Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2005
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Prostate Specific Antigen (PSA) Failures [ Time Frame: 3 months up to 2 years ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00388804     History of Changes
Other Study ID Numbers: 2003-0819
First Posted: October 17, 2006    Key Record Dates
Results First Posted: August 8, 2012
Last Update Posted: August 8, 2012
Last Verified: June 2012

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
Hormones
Leuprolide
Goserelin
Flutamide
Bicalutamide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists