Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.

Official Title
-----------------
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: GnRh (Leuprolide)
* Drug: Testosterone Gel
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC. Patient must have a serum testosterone > 180 ng/dl. Karnofsky performance status (KPS)>_70%. Patients must have adequate organ function as defined by the following laboratory criteria: WBC >_ 3500/mm3 ANC >_1500/mm3 Platelet count >100,000/mm3 Hemoglobin >8.0g/dL Creatinine <1.6mg/dl Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL) SGOT and SGPT If alkaline phosphatase is _< 2.5 x ULN, any elevations in AST/ALT; OR if AST/ALT is _<1.5 x ULN, any elevation in alkaline phos Prior hormonal therapy is allowed as: Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy). One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy). Patients must be at least 18 years of age. Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment Exclusion Criteria: Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease. Uncontrolled serious active infection. Anticipated survival of less than 3 months. Active CNS or epiduraltumor Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests Peripheral neuropathy >_ grade 3. Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment. Prior chemotherapy Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: GnRh (Leuprolide)<br>* Leuprolide LUPRON<br>* Other names: 22.5 mg intramuscular injection;Drug: Testosterone Gel<br>* Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)<br>* Other names: AndroGel;Drug: Docetaxel<br>* 70 mg/m2 given on day o1 of each 3 week cycle<br>* Other names: Taxotere;|
| Active Comparator: 2<br> | Drug: GnRh (Leuprolide)<br>* Leuprolide LUPRON<br>* Other names: 22.5 mg intramuscular injection;Drug: Testosterone Gel<br>* Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)<br>* Other names: AndroGel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy |  | Conclusion of the study (at 6 months then at 18 months post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of Testosterone Administration on Docetaxel Pharmacokinetics. | Docetaxel Pharmacokinetic parameters for cycles 1 and 2. | at Cycle 1 and 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Cancer, Docetaxel, 03-076