Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
Brief summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
Detailed description
OBJECTIVES: * Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer. * Determine the safety of EBRT+BT in these patients. * Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients. OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks. Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds. Patients are followed every 3 months for 2 years and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Interventions
DRUGLHRH agonist
Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
DRUGantiandrogen
flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
RADIATIONradiation therapy
4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
RADIATIONBrachytherapy boost
Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Must have one of the following prognostic factors: * Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score \> 6 * Stage T1-2, N0; PSA \> 10 ng/mL and \< 20 ng/mL; and Gleason score ≤ 6 * Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6 * Prostate volume \< 60 cc by transrectal ultrasound * No distant or nodal metastases * No metastatic disease by bone scan, CT scan, or MRI PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic: * Bilirubin ≤ 1.5 times upper limit of normal Renal: * Not specified Other: * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for prostate cancer Chemotherapy: * No prior chemotherapy for prostate cancer Endocrine therapy: * Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy * No other prior hormonal therapy Radiotherapy: * No prior radiotherapy for prostate cancer Surgery: * No prior surgery for prostate cancer * No prior transurethral resection of the prostate Other: * No prior alternative therapy (e.g., PC-SPES) for prostate cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | q 3 mon for 2 yrs post tx initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to PSA failure | 6 years | — |
| Survival | 6 years | Progression free and overall survival will be assessed |
Countries
United States
Outcome results
None listed