Intensity-Modulated Radiation Therapy, Docetaxel, and Hormone Therapy in Treating Patients With High-Risk Locally Advanced Prostate Cancer With Pelvic Lymph Node Metastasis

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Specialized radiation therapy that delivers a high- dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with chemotherapy and hormone therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with intensity-modulated radiation therapy and hormone therapy in treating patients with high-risk locally advanced prostate cancer with pelvic lymph node metastasis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bicalutamide; Docetaxel; Goserelin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Locally advanced disease (T1 -T3b, N1 or N2, M0) at high risk for recurrence

• Biopsy-proven pelvic lymph node involvement

• No T4 lesion

• Prior androgen suppression within the past 14 months is allowed provided the following criterion is met:

• No biochemical evidence of PSA progression after androgen withdrawal

• PSA progression, defined as 2 consecutive rising PSA values > 4.0 ng/mL taken ≥ 2 weeks apart

• No evidence of distant metastasis, including any of the following:

• Bone metastasis

• Pathologic or radiographic evidence of lymph node involvement above the L4 - L5 interspace

PATIENT CHARACTERISTICS:

• Karnofsky performance status 80-100%

• ANC ≥ 1,500/mm³

• Hemoglobin ≥ 10 g/dL

• Platelet count > 100,000/mm³

• Bilirubin normal

• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment

• Meets 1 of the following criteria:

• Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)

• AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

• AP ≤ 5 times ULN AND AST or ALT normal

• No peripheral neuropathy > grade 1

• No significant comorbidity that would preclude radiotherapy

• No other prior malignancy except nonmelanoma skin cancer or any other cancer for which the patient has been disease-free for the past 5 years

• No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

• No history of Crohn's disease, ulcerative colitis, or irritable bowel syndrome

• No unrepaired inguinal hernia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior pelvic or abdominal radiotherapy or prostate brachytherapy implant

• No prior prostatectomy

• No prior pelvic or abdominal surgery that resulted in excessive amounts of small intestine located within the pelvis

• No other concurrent investigational agents