Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer

• Status: Terminated
• Trial end date: 2016-07-08
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Docetaxel; Prednisone

Criteria

Inclusion Criteria:

• Histologically confirmed prostate cancer

• Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago

• No lymph node-positive prostate cancer

• No documented metastatic disease

• CT scan of the abdomen and pelvis negative (within the past 6 months)

• No bone pain OR negative bone scan (within the past 6 months)

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9 g/dL

• Bilirubin normal

• ALT and AST ≤ 1.5 times upper limit of normal

• Alkaline phosphatase normal

• Fertile patients must use effective contraception

• No peripheral neuropathy > grade 1

• No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer

• No serious illness with a life expectancy of < 5 years

• No concurrent medical, psychological, or social circumstance that would preclude study compliance

• No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

Exclusion Criteria:

• No prior orchiectomy

• No prior chemotherapy regimen for this disease

• No prior pelvic radiotherapy

• No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride

• Preoperative androgen manipulation for a duration of ≤ 3 months allowed

• No prior immunotherapy

• No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

• No concurrent herbal or alternative regimens including, but not limited to, any of the following:

• Saw palmetto

• PC-SPES

• Shark cartilage

• No other concurrent investigational agents

• No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)