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

 Primary

 -  Determine the rate of prostate-specific antigen (PSA) decline and the number of patients
 reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel
 and external-beam radiotherapy followed by docetaxel and prednisone in patients with
 hormone-naive prostate cancer who have a persistent or rising PSA after radical
 prostatectomy.

 Secondary

 -  Determine the tolerability of this regimen in these patients.

 -  Determine the progression-free survival, based on PSA progression, of these patients.

 -  Determine the overall survival of patients treated with chemoradiotherapy for rising PSA
 after radical prostatectomy.

 -  Determine if the velocity of subsequent PSA failure impacts survival of these patients.

 Tertiary

 -  Document subsequent therapy for patients whose previous treatment has failed and if
 there is a response to that therapy.

 Quaternary: To collect data on a contemporary cohort to those on study that received
 radiation alone. We will match cancer and patient characteristics to determine if the
 variable of chemotherapy has any impact on outcomes.

 OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and
 undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.

 Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel IV
 over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21
 days for 4 courses in the absence of disease progression or unacceptable toxicity.

 After completion of study treatment, patients are followed at 1 month, every 4 months for 2
 years, and then every 6 months for 3 years.

 PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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)