Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer

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: NCT00003915
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
University of Massachusetts, Worcester

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide and leuprolide may fight prostate cancer by reducing the production of androgens.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy consisting of docetaxel and estramustine plus hormone therapy in treating patients who have previously undergone radiation therapy or surgical removal of the prostate for stage I prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bicalutamide Drug: docetaxel Drug: estramustine phosphate sodium Drug: leuprolide acetate Phase 2

Detailed Description:


  • Determine the feasibility of administering docetaxel plus estramustine in combination with androgen deprivation therapy in patients with PSA elevation following radiotherapy or radical prostatectomy for early prostate cancer.
  • Evaluate this regimen in terms of PSA response rate, response duration, and time to future therapeutic intervention in this patient population.
  • Evaluate testosterone, free testosterone, and sex hormone binding globulin in relation to this treatment regimen in these patients.

OUTLINE: Patients receive oral estramustine three times a day on days 1-5 and docetaxel IV over 1 hour on day 2. Treatment repeats every 3 weeks for 4 courses.

Patients receive oral bicalutamide daily beginning on week 12 and leuprolide intramuscularly every 3 months beginning on week 13. Treatment continues for 15 months.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6 months thereafter until disease progression and/or subsequently until death. Information will be collected on subsequent prostate cancer treatments, time to and nature of first evidence of metastatic prostate cancer, and the date and cause of death.

PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
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
Study Start Date : May 1999
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: treatment Drug: bicalutamide
Drug: docetaxel
Drug: estramustine phosphate sodium
Drug: leuprolide acetate

Primary Outcome Measures :
  1. PSA Progression Free Survival [ Time Frame: years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • No metastases
  • No measurable or evaluable disease
  • 2 consecutively rising PSA levels at least 2 weeks apart, despite prior radical prostatectomy or radiotherapy (external beam or implant)

    • PSA risen to twice nadir value post radiotherapy



  • Not specified

Performance status:

  • 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than upper limit of normal (ULN)
  • Must meet 1 of the following criteria:

    • SGOT and/or SGPT no greater than 2.5 times ULN AND alkaline phosphatase no greater than ULN
    • Alkaline phosphatase no greater than 4.0 times ULN AND SGOT and/or SGPT no greater than ULN
    • SGOT and SGPT no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN


  • Not specified


  • At least 6 months since prior myocardial infarction, angina, or New York Heart Association class III or IV heart disease
  • No active thrombophlebitis
  • At least 6 months since prior thromboembolic events including deep vein thrombosis and cerebrovascular accident


  • No other malignancies within the past 5 years except curatively treated basal cell skin cancer
  • No active infection
  • No significant neuropathy


Biologic therapy:

  • Not specified


  • No prior estramustine or suramin

Endocrine therapy:

  • At least 6 months since prior neoadjuvant or adjuvant hormonal therapy of no greater than 6 months duration
  • No concurrent corticosteroids


  • Salvage radiotherapy post prostatectomy allowed


  • See Disease Characteristics

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): NCT00003915

United States, Massachusetts
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, 03756-0002
Sponsors and Collaborators
University of Massachusetts, Worcester
Principal Investigator: William Walsh, MD University of Massachusetts, Worcester

Responsible Party: University of Massachusetts, Worcester Identifier: NCT00003915     History of Changes
Other Study ID Numbers: CDR0000067095
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by University of Massachusetts, Worcester:
adenocarcinoma of the prostate
stage I prostate cancer

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