MDX-010 for Advanced Prostate Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

March 10, 2008

Start Date ^†

June 2005

Current Primary Outcome Measures ^†

Primary endpoint will be the proportion of patients remaining progression-free [ Time Frame: 18 months from the time patient receives the MDX-010. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00170157 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Monitor the initial PSA response which encompasses absolute nadir value, time-until-nadir, and greatest percent decline in PSA (at nadir) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

MDX-010 for Advanced Prostate Cancer

Official Title ^†

A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer

Brief Summary

A total of 108 males with advanced prostate cancer will be enrolled into this study. Patients must have undergone prostate cancer staging within 180 days of enrollment. 54 patients will be randomized to receive hormone therapy alone and 54 patients will be randomized to receive hormone therapy plus the MDX-010 therapy.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Condition ^†

Prostatic Neoplasms

Intervention ^†

Drug: Combination Androgen Ablative Therapy

Study Arms / Comparison Groups

Experimental: 3 months of concurrent AA therapy + MDX-010
Active Comparator: 3 months of initial AA therapy alone

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

108

Completion Date

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Males 18 years of age or older with histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, any T stage, with or without metastases, with an initial PSA of ≥4.0 ng/ml may be eligible for enrollment into this protocol. Participants may not have underwent prior systemic chemotherapy or prior radiation therapy to the prostate. Includes post radical prostatectomy patients with a rising PSA and patients who have started hormone therapy ≤21 days

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00170157

Responsible Party

Eugene Dai Kwon, M.D., Mayo Clinic

Secondary IDs ^††

DAMD17-02-1-0245

Study Sponsor ^†

Mayo Clinic

Collaborators ^††

Department of Defense
U.S. Army Medical Research Acquisition Activity
Medarex

Investigators ^†

Principal Investigator:

Eugene D. Kwon, M.D.

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.