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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Given intravenously on day 2 of four three-week cycles | ||
| Estramustine | Drug | Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles) | ||
| Casodex | Drug | Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months | ||
| Zoladex | Drug | Started one week after the start of casodex; zolades is given as an injection (in the stomach once every 3 months for a total of 5 injections. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Beth Israel Deaconess Medical Center |
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| Boston |
| Massachusetts |
| 02215 |
| United States |
| Lahey Clinic-Burlington | Burlington | Massachusetts | 01805 | United States |
| University of Massachusetts Memorial Medical Center-University Campus | Worcester | Massachusetts | 01655 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 037566-0002 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D004961 | Estramustine |
| C053541 | bicalutamide |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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