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

This study has been terminated.
(Study closed. Difficult enrollment of patients with prostatitis.)
Sponsor:
Collaborators:
Celgene Corporation
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00301405
First received: March 9, 2006
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Chronic Prostatitis
Pelvic Pain
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Decrease in pain as measured by visual analog scale [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: March 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thalidomide
Open Label drug
Drug: Thalidomide
Open label drug

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male subjects aged 18 and older.
  2. Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies
  3. Subjects with a minimum score of 15 on the CPSI.
  4. Male subjects must give written informed consent.
  5. Male subjects must be willing an able to comply with the most recent version of the FDA-mandated S.T.E.P.S.â Program to include:

    • He understands and can reliably carry out all instructions.
    • He is capable of complying with the mandatory contraceptive measures that are appropriate for male patient registration, and patient surveys as described in the S.T.E.P.S.â program.
    • He has received both oral and written warning of the hazards of taking thalidomide and exposing a fetus to the drug
    • He has received both oral and written warning of the risk of possible contraception failure and of the presence of thalidomide in semen. He has been instructed that he must always use a late condom during any sexual contact with a woman of childbearing potential, even if he has undergone a successful vasectomy.
    • He acknowledges in writing his understanding of these warning and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy.
    • He agrees NOT to be a sperm or blood donor while being treated with thalidomide -

Exclusion Criteria:

  1. Subjects who are female.
  2. Subjects with a documented positive urine culture (>100,000 CFU/mL) within the past six months
  3. Subjects with duration of symptoms less than three months
  4. Subjects with active genital infections
  5. Subjects with prior urologic surgeries
  6. Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate
  7. Subjects having received prior radiation to the abdominal or pelvic area
  8. Subjects with known bladder or ureteral calculi
  9. Subjects unable to complete a voiding diary
  10. Subjects diagnosed with neuropathy
  11. Subjects with neutropenia
  12. Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state
  13. Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program
  14. Subjects with orthostatic hypotension
  15. Subjects with known malignancies in the last 2 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301405

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
Celgene Corporation
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospital Hospital
  More Information

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00301405     History of Changes
Other Study ID Numbers: 2005-149 IND #74,062
Study First Received: March 9, 2006
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by William Beaumont Hospitals:
prostatitis
pelvic pain

Additional relevant MeSH terms:
Pelvic Pain
Prostatitis
Chronic Disease
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014