COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00067015
Recruitment Status : Completed
First Posted : August 11, 2003
Last Update Posted : December 22, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue and may improve quality of life and help patients live more comfortably. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the production of androgens. It is not yet known whether radiation therapy is more effective with or without goserelin and bicalutamide in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy with or without bicalutamide and goserelin in treating patients who have prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bicalutamide Drug: goserelin acetate Procedure: assessment of therapy complications Procedure: quality-of-life assessment Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the quality of life of patients with high-grade intermediate-risk or unfavorable-risk adenocarcinoma of the prostate when treated with high-dose intensity-modulated radiotherapy alone versus with androgen deprivation comprising bicalutamide and goserelin.
  • Compare the prostate-specific antigen relapse-free, distant metastases-free, and overall survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the local control in patients treated with these regimens, based on post-treatment sextant biopsies performed 4 years after study completion.

OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level, Gleason score, and clinical stage. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo high-dose intensity-modulated radiotherapy (IMRT) 4-5 times per week for 10 weeks (a total of 48 treatments).
  • Arm II: Patients receive oral bicalutamide once daily for 18.5 weeks. Three to seven days after the initiation of bicalutamide, patients also receive goserelin subcutaneously monthly for 2 years. Beginning after 10 weeks of hormonal therapy, patients undergo concurrent high-dose IMRT 4-5 times per week for 8.5 weeks (a total of 42 treatments). Patients discontinue bicalutamide on or near the end of radiotherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1.5 years after the completion of radiotherapy, then 6 months later, and then annually for 2 years.

Patients are followed every 6-8 months for 4 years and then annually for 2 years.

PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 4-5 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial Study Comparing the Outcome of High-Dose IMRT (86.4 GY) Alone With IMRT to 75.6 GY Plus Neoadjuvant/Adjuvant Androgen Deprivation in Patients With High Grade Intermediate Risk and Unfavorable Risk Prostate Cancer
Study Start Date : May 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: IMRT alone to 86.4 Gy
External radiotherapy is given for 10 weeks, Monday through Friday for a total of 48 sessions. The total dose of radiotherapy delivered during these 10 weeks is 86.4 Gy. The radiation treatments are delivered with a high precision technique called intensity modulated radiotherapy or IMRT. For this treatment, no hormonal therapy is required.
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Radiation: radiation therapy
Experimental: IMRT TO 75.6 Gy plus Adjuvant Androgen Deprivation
Prior to a planned course of radiotherapy, which will last for eight and a half weeks, 10 weeks of hormonal therapy are given. The hormonal therapy will start with a daily pill called Casodex. Three to seven days after starting this pill, a Zoladex injection will be administered in addition to the Casodex pill. Zoladex hormonal therapy is given in the form of a monthly injection. After 10 weeks from the initiation of hormone therapy, you will begin external radiotherapy. For these treatments only 42 treatment sessions are given. The total dose of radiotherapy delivered during these 8.5 weeks is 75.6 Gy. The hormone injections continue during the radiation treatments and for 2 years after the radiation treatments. The pills are only taken for the 10 weeks before and also during the radiation treatments, however afterwards the pills are discontinued.
Drug: bicalutamide
Drug: goserelin acetate
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Radiation: radiation therapy

Primary Outcome Measures :
  1. compare the quality of life [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. response [ Time Frame: 2 years ]
  2. toxicity [ Time Frame: 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate
  • Unfavorable-risk disease, including at least 2 of the following characteristics:

    • Prostate-specific antigen level greater than 10 ng/mL
    • Gleason score greater than 7
    • Stage T4
  • Intermediate-risk disease with a Gleason score of at least 8 allowed
  • Lymph nodes clinically negative by imaging studies or histologically negative by node sampling or lymph node dissection
  • Prostate size less than 75 grams
  • No distant metastases by bone scan, CT scan, or MRI



  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 1.5 times ULN


  • Not specified


  • No documented history of inflammatory bowel disease
  • No bilateral hip replacements
  • No other invasive cancer except localized basal cell or squamous cell skin cancer unless disease free for at least 5 years
  • No major medical or psychiatric illness that would preclude study completion, compliance, or follow-up


Biologic therapy

  • Not specified


  • No prior chemotherapy for prostate cancer

Endocrine therapy

  • No prior androgen-deprivation therapy


  • No prior pelvic radiotherapy
  • No prior prostate brachytherapy


  • No prior bilateral orchiectomy
  • No prior radical prostatectomy
  • No prior cryotherapy for prostate cancer

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 identifier (NCT number): NCT00067015

Layout table for location information
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Michael J. Zelefsky, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00067015    
Other Study ID Numbers: 03-040
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2003    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Keywords provided by Memorial Sloan Kettering Cancer Center:
adenocarcinoma of the prostate
stage III prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs