Clinical Trial: Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain

Brief Summary: To determine the efficacy of thalidomide for treatment of the Chronic Pelvic Pain Syndrome (CPPS).

Detailed Summary:

Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and decreased quality of life. Little is known about the cause of CP/CPPS and no definitive therapy exists.

Thalidomide is an immunomodulator (a drug that alters the immune system) and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, but not for the treatment of CP or CPPS.


Sponsor: Kenneth Peters, MD

Current Primary Outcome: Decrease in pain as measured by visual analog scale

Original Primary Outcome:

  • 1) Decrease in pain as measured by visual analog scale using daily Visual Pain Analog Scale (appendix V)
  • 2) Improvement in symptoms as measured by CPSI (Chronic Prostatitis Symptom Index)
  • 3) Improvement in sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)


Current Secondary Outcome:

Original Secondary Outcome:

  • 1) Global Assessment Scale (appendix VII) to be done at baseline and at every monthly visit.
  • 2) SF-12Ò Health Survey


Information By: William Beaumont Hospitals

Dates:
Date Received: March 9, 2006
Date Started: March 2006
Date Completion:
Last Updated: August 1, 2013
Last Verified: August 2013