Testosterone in Castration-Resistant Prostate Cancer

This study has been terminated.

( Zero accrual and failure to generate multicenter interest. )

Study NCT00577980 Information provided by M.D. Anderson Cancer Center

First Received on December 17, 2007. Last Updated on October 7, 2009 History of Changes

Results First Received: September 4, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Intervention:	Drug: Testosterone

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 01/16/08 through 06/04/08. All participant recruitment attempts made at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No patients were enrolled.

Reporting Groups

	Description
Testosterone	No text entered.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Testosterone	No text entered.

Baseline Measures

	Testosterone
Number of Participants [units: participants]	0
Age [units: participants]
<=18 years	0
Between 18 and 65 years	0
>=65 years	0
Gender [units: participants]
Female	0
Male	0
Region of Enrollment [units: participants]
United States	0

Outcome Measures

1. Primary:

Rate of PSA-decline by 50% [ Time Frame: Every 2 weeks, after Week 8 every 4 weeks till end of study ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Zero accrual over 6 months and failure to generate multicenter interest led to decision to terminate.

Results Point of Contact:

Name/Title: Paul Mathew, MD / Assistant Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-2833

No publications provided

Responsible Party:	Paul Mathew, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00577980 History of Changes
Other Study ID Numbers:	2006-0316
Study First Received:	December 17, 2007
Results First Received:	September 4, 2009
Last Updated:	October 7, 2009
Health Authority:	United States: Institutional Review Board