Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment

Phase 2

Completed

Brief Summary: The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer.

This study will attempt to:

* stop or slow the growth of disease

* gain information about prostate cancer

* evaluate the effectiveness and side effects of the study drug

Detailed Description: * Patients will receive two medications; docetaxel and estramustine. Estramustine will be taken orally three times daily for 5 days starting on day one. Docetaxel will be given intravenously on day 2. These two drugs will be repeated every 3 weeks for a total of 4 cycles (12 weeks).

* Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects.

* Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots.

* After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment. Three weeks after the last chemotherapy treatment, patients will start Casodex orally once daily.

* After taking Casodex for 1 week, patients will then start on Zoladex (an injection in the abdomen) every 3 months for a total of 5 injections.

* During study treatment various blood tests will be performed to watch the disease. Study treatment will stop after a total of 18 months (3 months chemotherapy and 15 months hormone therapy). A physical exam and blood tests will be performed every 3 months for 2 years, every 4 months for the third year, and then every 6 months after that.

Recruitment & Eligibility

Inclusion Criteria

Histologically documented adenocarcinoma of the prostate
Previous treatment with either radical prostatectomy or radiation therapy
Post prostatectomy: PSA rising on at least two successive occasions at least two weeks apart
Post radiation therapy alone: PSA has to be rising as documented on two successive occasions at least two weeks apart and also have doubled from the nadir post treatment value
ECOG performance status 0-1
ANC > 1,500/mm3
Platelet counts > 100,000/mm3
SGOT and/or SGPT may be up to 2.5 x ULN

Exclusion Criteria

Documented local recurrence of prostate cancer or documented metastatic disease
History of other malignancy within the last 5 years, other than curatively treated basal cell carcinoma of the skin
Medical condition requiring the use of concommitant corticosteroids
Active infection
Significant cardiac disease, angina pectoris or myocardial infarction within six months
Prior chemotherapy including estramustine, suramin
Active thrombophlebitis or history of thromboembolic events in the six months preceding study treatment
Clinically significant neuropathy
Elevated bilirubin above ULN

Primary Outcome Measures

Name	Time	Method
To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.	2 years

Secondary Outcome Measures

Name	Time	Method
To determine the PSA response rate and duration of response
to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy.	2 years

Locations (5): University of Massachusetts Memorial Medical Center-University Campus
🇺🇸
Worcester, Massachusetts, United States
Norris Cotton Cancer Center
🇺🇸
Lebanon, New Hampshire, United States
Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Lahey Clinic-Burlington
🇺🇸
Burlington, Massachusetts, United States

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