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

June 21, 2018 updated by: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Burlington, Massachusetts, United States, 01805
    - Lahey Clinic-Burlington
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Memorial Medical Center-University Campus
- New Hampshire
  - Lebanon, New Hampshire, United States, 037566-0002
    - Norris Cotton Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	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. Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2004

Primary Completion (ACTUAL)

December 31, 2005

Study Completion (ACTUAL)

December 31, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria