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Docetaxel + Prednisone With or Without Radiation for Castrate Resistant Prostate Cancer

NCT01087580 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-03-03

No results posted yet for this study

Summary

The main purpose of this study is to find out whether adding radiation therapy to the standard treatment of chemotherapy for prostate cancer is tolerated well and is more effective than the standard treatment of chemotherapy alone

Conditions

Interventions

DRUG

Docetaxel and Prednisone

A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel

DRUG

Docetaxel and Prednisone

A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel

DRUG

Radiation Therapy

GROUPS 1 and 2 Whole Pelvis (45 Gy) + Prostate boost (20-25 Gy) in 1.8 Gy fractions, 5 fractions/week. GROUPS 2 Bone metastasis (bone scan index \< 1.4%): 30 Gy in 10 fractions or 35 Gy in 12 fractions. GROUPS 1,2 Abdominal Nodes (IF POSITIVE ON CT/MRI SCAN): 45-50 Gy in 1.8 Gy fractions, 5 fractions/week.

Sponsors & Collaborators

Principal Investigators

  • John Kalapurakal, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087580 on ClinicalTrials.gov