Tetrathiomolybdate in Hormone Refractory Prostate Cancer
Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the treatment of hormone refractory prostate cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trail of Tetrathiomolybdate in Patients With Hormone Refractory Prostate Cancer|
- Time to Progression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To determine the time to progression of prostate cancer in patients with androgen-independent prostate cancer treated with tetrathiomolybdate. Disease progression is defined as at least a 20% increase in the sum of the longest diameter of the target lesions. For disease evaluable only by bone scan, the appearance of new lesions was considered evidence of progression. The development of pain in an existing lesion requiring institution of palliative radiotherapy or prescription narcotics was also considered evidence of progression.
|Study Start Date:||May 2001|
|Study Completion Date:||April 2006|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
Patients will be started on a dose of 60mg Tetrathiomolybdate at bedtime and 40mg 3 times per day.
Tetrathiomolybdate or TM, a drug developed for Wilson's Disease, removes copper from the bloodstream. Copper is a key factor in angiogenesis (blood vessel growth)- a process that occurs normally in the body but becomes uncontrolled in cancerous cells. Tetrathiomolybdate essentially wages war against copper, which serves to choke off tumor growth. Realizing the key role of copper in angiogenesis, researchers have begun exploring treatment with Tetrathiomolybdate for different types of cancers. This clinical trial will evaluate the effectiveness of Tetrathiomolybdate in the treatment of patients with hormone refractory prostate cancer. Hormone refractory prostate cancer refers to advanced disease in which the patient no longer responding to conventional hormonal treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150995
|United States, Michigan|
|The University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||David C. Smith, MD||The University of Michigan Comprehensive Cancer Center|