Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
18 Years
N/A
Male
Adenocarcinoma of the Prostate, Prostate Cancer
Trial Information
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
- 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Mary-Ellen Taplin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
03-230
NCT ID:
NCT00165399
Start Date:
March 2004
Completion Date:
December 2012
Related Keywords:
- Adenocarcinoma of the Prostate
- Prostate Cancer
- Prostate cancer
- PSA level
- docetaxel
- estramustine
- hormone therapy
- androgen withdrawal
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
