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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165399
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 25, 2018
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Prostate Cancer Drug: Docetaxel Drug: Estramustine Drug: Casodex Drug: Zoladex Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
Actual Study Start Date : March 2004
Actual Primary Completion Date : December 31, 2005
Actual Study Completion Date : December 31, 2005

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Docetaxel
    Given intravenously on day 2 of four three-week cycles
  • Drug: Estramustine
    Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)
  • Drug: Casodex
    Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 months
  • Drug: Zoladex
    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.

Primary Outcome Measures :
  1. To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To determine the PSA response rate and duration of response
  2. to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy. [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165399

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic-Burlington
Burlington, Massachusetts, United States, 01805
University of Massachusetts Memorial Medical Center-University Campus
Worcester, Massachusetts, United States, 01655
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 037566-0002
Sponsors and Collaborators
Dana-Farber Cancer Institute
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute

Responsible Party: Mary-Ellen Taplin, MD, Associate Professor of Medicine, HMS, Dana-Farber Cancer Institute Identifier: NCT00165399     History of Changes
Obsolete Identifiers: NCT00003915
Other Study ID Numbers: 03-230
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Keywords provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:
Prostate cancer
PSA level
hormone therapy
androgen withdrawal

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents, Alkylating
Alkylating Agents