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CompletedNCT00150995Updated Jan 21, 2015

Tetrathiomolybdate in Hormone Refractory Prostate Cancer

A Phase 2 interventional study of Tetrathiomolybdate in Prostate Cancer, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-21.

Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
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Study summary

Purpose: The aim of this clinical trail is to evaluate Tetrathiomolybdate (TM) in the treatment of hormone refractory prostate cancer.

Read the detailed description

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.

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 19 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

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)
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Tetrathiomolybdate

    Patients will be started on a dose of 60mg Tetrathiomolybdate at bedtime and 40mg 3 times per day.

    Drug: Tetrathiomolybdate

Interventions

  • DrugTetrathiomolybdate
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What researchers measure

Primary outcomes

  1. Time to Progression

    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.

    Time frame: 12 weeks

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Study locations

1 site
  • The University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00150995
Lead sponsor
University of Michigan Rogel Cancer Center
Responsible party
Sponsor
First posted
Sep 8, 2005
Start date
May 2001
Primary completion
Oct 2003
Completion
Apr 2006
Last update
Jan 21, 2015

Study contacts

David C. Smith, MD
principal investigator · The University of Michigan Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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