Completed

Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

docetaxel

Drug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 1999
See protocol details

Summary

Principal SponsorDana-Farber Cancer Institute
Last updated: July 14, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients. OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.

NCT00005096
Principal SponsorDana-Farber Cancer Institute
Last updated: July 14, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

2 exclusion criteria prevent from participating
Evidence of serious active infection
No prior hormones, radiation or chemotherapy for prostate cancer

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Docetaxel given via iv at determined dose once a week for 4 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps

Beth Israel Deaconess Medical Center

Boston, United States

Dana-Farber Cancer Institute

Boston, United States
Completed3 Study Centers