Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | May 2003 |
| End Date: | September 2008 |
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
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.
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.
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.
- 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.
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
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