A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer

Selenium, in the form of inorganic Sodium Selenite, may be useful for treating existing prostate cancer. This idea is based on data from our laboratory showing that 1) prostate cancer cells are more sensitive to Selenium (Sodium Selenite)-induced apoptosis than normal prostate epithelial cells, 2) Selenite induces significant growth inhibition of well established prostate cancer tumors in mice at doses that have no detectable toxicity, and 3) Selenite disrupts AR signaling, and that the inhibition of AR expression and activity by Selenite occurs via a redox mechanism involving GSH, superoxide, and Sp1. Altogether, these findings suggest that Selenium may be useful in a variety of potential indications in the natural history of prostate cancer, including both hormone sensitive and castrate resistant prostate cancer, as a single agent, or in combination with radiation, chemotherapy or conventional hormone therapy. Selenite is a potential novel inhibitor of AR expression and function in prostate cancer.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Biosyn
  • drug : Docetaxel
  • drug : Prednisone

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of the prostate 2. Castration-resistant prostate cancer requires the following 3 criteria: - Failure of first line bilateral orchiectomy or therapy with an LHRH agonist, - A rising PSA on 3 consecutive occasions at least 1 week apart (but not limited to the 30 day screening period), AND - A castrate level of testosterone (<50ng/dL) 3. PSA doubling time (PSADT) > 1 months 4. Failure on docetaxel chemotherapy as defined by a rising PSA . 5. A minimum PSA of 2 ng/mL 6. Age >=18 years 7. Life expectancy greater than 6 months 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Karnofsky performance status >=80% 9. Bone metastases will be allowed 10. The subject has a QTcB (Bazett corrected) or QTcF (Frederica corrected) < 470 msec. 11. Ability to understand and the willingness to sign a written informed consent document. 12. Willingness to stay on docetaxel chemotherapy despite rising PSA level.

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Contact information

Primary Contact:

Denise Haas 6507361252

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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