Docetaxel With Rapid Hormonal Cycling As A Treatment For Patients With Prostate Cancer
- Determine the efficacy of rapid hormonal cycling with testosterone and leuprolide in
combination with docetaxel, in terms of obtaining a durable decline in
prostate-specific antigen level or reduction of abnormal sites of disease, in patients
with recurrent or non-castrate metastatic adenocarcinoma of the prostate.
- Determine the safety of this regimen in these patients.
- Determine the antitumor effects and changes in measurable disease in patients treated
with this regimen.
- Determine the affects of testosterone administration on CYP3A activity and docetaxel
pharmacokinetics in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to clinical state
(rising prostate-specific antigen vs non-castrate metastatic disease).
Patients receive leuprolide intramuscularly and docetaxel IV over 1 hour on day 1 and
testosterone gel topically on days 22-28. Treatment repeats every 28 days for 6 courses* in
the absence of disease progression or unacceptable toxicity.
NOTE: *Testosterone gel is applied only during courses 1-5.
Patients are followed monthly for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 76 patients (38 per stratum) will be accrued for this study
within approximately 2 years.
Masking: Open Label, Primary Purpose: Treatment
PSA ≤ 0.05 ng/mL after radical prostatectomy
Dana Rathkopf, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|