Overview

Tetrathiomolybdate in Hormone Refractory Prostate Cancer

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
Male
Summary
Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the treatment of hormone refractory prostate cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Michigan Cancer Center
University of Michigan Rogel Cancer Center
Treatments:
Hormones
Molybdenum
Tetrathiomolybdate
Criteria
Inclusion:

- Patients must have histologic diagnosis of adenocarcinoma of the prostate with
progression following hormonal therapy and antiandrogen withdrawal.

- Patients must have minimal disease (defined as bone metastasis or visceral disease
with no impairment of organ function or pain severe enough to require narcotics for
control).

- Adequate bone marrow and renal function

- ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (a measure of general well
being where 1 represents asymptomatic and 5 represents death)

- Life expectancy of at least 16 weeks

- Must have completed radiation more than 4 weeks prior to registration and must have a
rising PSA (Prostate Specific Antigen) and lesion outside of the radiation field

Exclusion:

- Patients with an elevated PSA as the only evidence of disease

- Clinical evidence of spinal cord compression

- History of prior malignancy within the past 5 years (with the exception of in situ
carcinoma of any site or nonmelanoma skin cancer)