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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00067015
First received: August 8, 2003
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • compare the quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: May 2003
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

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

Renal

  • Not specified

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for prostate cancer

Endocrine therapy

  • No prior androgen-deprivation therapy

Radiotherapy

  • No prior pelvic radiotherapy
  • No prior prostate brachytherapy

Surgery

  • No prior bilateral orchiectomy
  • No prior radical prostatectomy
  • No prior cryotherapy for prostate cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067015

Locations
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)
Investigators
Principal Investigator: Michael J. Zelefsky, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00067015     History of Changes
Other Study ID Numbers: 03-040, P30CA008748, MSKCC-03040
Study First Received: August 8, 2003
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
adenocarcinoma of the prostate
stage III prostate cancer

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

ClinicalTrials.gov processed this record on May 23, 2013