CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Docetaxel +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01250717
NCT01250717Phase 2Completed

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

Beth Israel Deaconess Medical Center·interventional·Posted Dec 1, 2010·Updated Feb 4, 2014

In Brief

A Phase 2 clinical trial evaluating Docetaxel, Dexamethasone, and 4 other interventions for Prostate Cancer. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 1, 2010
Enrollment StartJan 1, 2001
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 15.6 years ago

Interventions

Docetaxeldrug

Given by an IV infusion over 1 hour on day 2 of a three-week cycle

Dexamethasonedrug

Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel

Estramustinedrug

Taken orally three times a day for 5 days for the first part of every three week cycle

Zoladexdrug

Given subcutaneously for 4 doses every three months

Casodexdrug

Taken orally once a day for 6 months

Radical Prostatectomyprocedure

after the chemo and hormonal therapy all patients have a radiacal prostatectomy