Clinical trial NCT00165399: Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
Official title: Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Prostate
Prostate Cancer
Keywords: Prostate cancer
PSA level
docetaxel
estramustine
hormone therapy
androgen withdrawal
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the PSA response rate and duration of response
measure: to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic-Burlington
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center-University Campus
state: Massachusetts
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary-Ellen Taplin, MD
role: PRINCIPAL_INVESTIGATOR
References: