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

NCT00388804 | Terminated Phase 3 Results DMC

• 1 other identifier: 2003-0819
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; External Beam Radiotherapy; Radiation Therapy; Hormone Therapy; Bicalutamide; Casodex; Leuprolide; Lupron; Goserelin; Zoladex; Flutamide; EBRT

Outcome Measures

Primary Outcomes (1)

• Prostate Specific Antigen (PSA) Failures

  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.

  3 months up to 2 years

Study Arms (2)

RT Group 1

ACTIVE COMPARATOR

Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.

Procedure: Radiation Therapy; Behavioral: Questionnaire

RT Group 2 + Hormone Therapy

ACTIVE COMPARATOR

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; Drug: Bicalutamide; Drug: Leuprolide; Drug: Goserelin; Drug: Flutamide; Behavioral: Questionnaire

Interventions

Radiation Therapy PROCEDURE

Radiation treatment given over about 8 1/2 weeks; 42 treatments, 5 days per week with 2 days rest in between.

Also known as: RT, XRT

RT Group 1; RT Group 2 + Hormone Therapy

Bicalutamide DRUG

50 mg By Mouth (PO) Daily

Also known as: Casodex

RT Group 2 + Hormone Therapy

Leuprolide DRUG

22.5 mg Intramuscularly (IM) Every 3 Months or 7.5 mg IM Every 1 Month

Also known as: Lupron

RT Group 2 + Hormone Therapy

Goserelin DRUG

10.8 mg Subcutaneously Every 3 Months or 3.6 mg Subcutaneously Every 1 Month

Also known as: Zoladex

RT Group 2 + Hormone Therapy

Flutamide DRUG

250 mg by mouth three times daily on first 21-30 Days. May be used instead of Bicalutamide.

RT Group 2 + Hormone Therapy

Questionnaire BEHAVIORAL

Questionnaires regarding health-related quality of life given before therapy begins, each taking about 15 minutes to complete.

Also known as: Survey

RT Group 1; RT Group 2 + Hormone Therapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven prostate cancer within last 12 months. Pathology must be reviewed at M.D. Anderson Cancer Center (MDACC).
• 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)
• AJCC clinical stage T2b on physical exam with biopsy Gleason sum of 7 or less and/or PSA \< 20 ng/ml
• 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.
• No evidence of metastatic disease on bone scan within 3 months of study enrollment.
• No evidence of metastatic disease on pelvic computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months of study enrollment.
• Zubrod performance status \< 2.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.)
• Previous or concurrent malignancies other than basal or squamous cell skin cancers unless disease-free for 5 years or more.
• Prior pelvic radiation or chemotherapy. Patients who received chemotherapy for non-prostate cancer malignancies over 5 years prior will be eligible.
• Prior or planned radical prostate surgery.
• 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.
• Other histologies such as small cell carcinoma, sarcomatoid or ductal variants are not eligible.
• Patients with any Gleason grade 5 disease on biopsy will not be eligible.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; bicalutamide; Leuprolide; Goserelin; Flutamide; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Andrew Lee, MD / Professor
• Organization: UT MD Anderson Cancer

lhamblin@mdanderson.org

Study Officials

• Andrew K. Lee, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2006
• First Posted: October 17, 2006
• Study Start: February 1, 2005
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 8, 2012
• Results First Posted: August 8, 2012

Record last verified: 2012-06

Locations

US (1)