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Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients With Prostate Cancer

NCT02494713 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-11-27

Study results available
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Summary

This is a study for men who have locally-advanced prostate cancer and are eligible to undergo prostatectomy. Standard treatment is prostatectomy alone, but there is a chance that cancer may spread to other organs in the future, even after the prostate is removed. If this were to occur, standard treatment would be androgen deprivation therapy (ADT; hormone therapy that blocks testosterone) plus chemotherapy. Clinical trials suggest that neoadjuvant treatment (treatment given before primary therapy) may prevent a recurrence. The purpose of this research study is to assess the safety and benefit of ADT plus chemotherapy given before prostate removal.

Conditions

Interventions

DRUG

Degarelix

Subcutaneous injection, once/month for 4 months

DRUG

Doxorubicin

20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5

DRUG

Ketoconazole

400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5

DRUG

Docetaxel

35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6

DRUG

Estramustine

280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Robert J Amato, D.O. · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-14
Completion
2017-09-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02494713 on ClinicalTrials.gov