A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
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.
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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of prostate-specific antigen (PSA) decline and the number of subjects reaching a PSA nadir of zero following the intervention.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Gregory P. Swanson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Texas Health Science Center at San Antonio
Authority:
United States: Federal Government
Study ID:
CDR0000486733
NCT ID:
NCT00348816
Start Date:
May 2006
Completion Date:
December 2014
Related Keywords:
- Prostate Cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
