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

Sponsors and Collaborators:	William Beaumont Hospitals Celgene Corporation
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00301405

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 II

MedlinePlus related topics: Pelvic Pain

Drug Information available for: Thalidomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	March 2006
Study Completion Date:	September 2007

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:

Male subjects aged 18 and older.
Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies
Subjects with a minimum score of 15 on the CPSI.
Male subjects must give written informed consent.
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:

Subjects who are female.
Subjects with a documented positive urine culture (>100,000 CFU/mL) within the past six months
Subjects with duration of symptoms less than three months
Subjects with active genital infections
Subjects with prior urologic surgeries
Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate
Subjects having received prior radiation to the abdominal or pelvic area
Subjects with known bladder or ureteral calculi
Subjects unable to complete a voiding diary
Subjects diagnosed with neuropathy
Subjects with neutropenia
Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state
Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program
Subjects with orthostatic hypotension
Subjects with known malignancies in the last 2 years.

Contacts and Locations

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

William Beaumont Hospitals

Celgene Corporation

Investigators

Principal Investigator:

Kenneth Peters, MD

William Beaumont Hospital Hospital

More Information

No publications provided

Study ID Numbers:	74,062
Study First Received:	March 9, 2006
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00301405 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by William Beaumont Hospitals:

prostatitis
pelvic pain

Study placed in the following topic categories:

Prostatitis
Anti-Bacterial Agents
Signs and Symptoms
Pelvic Pain
Immunologic Factors
Thalidomide

Prostatic Diseases
Chronic Disease
Pain
Genital Diseases, Male
Angiogenesis Inhibitors
Immunosuppressive Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Disease Attributes
Prostatic Diseases
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Pain
Genital Diseases, Male
Angiogenesis Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Prostatitis
Anti-Bacterial Agents
Signs and Symptoms
Pelvic Pain
Pathologic Processes
Therapeutic Uses
Chronic Disease
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on May 07, 2009