Status:
TERMINATED
Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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. Radiat...
Detailed Description
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 docetaxe...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00348816
Start Date
May 1 2006
End Date
July 8 2016
Last Update
December 8 2017
Active Locations (1)
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1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900