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

Primary Purpose

Chronic Prostatitis, Pelvic Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
Kenneth Peters, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis focused on measuring prostatitis, pelvic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • William Beaumont Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Thalidomide

Arm Description

Open Label drug

Outcomes

Primary Outcome Measures

Decrease in pain as measured by visual analog scale

Secondary Outcome Measures

Full Information

First Posted
March 9, 2006
Last Updated
August 1, 2013
Sponsor
Kenneth Peters, MD
Collaborators
Celgene Corporation, William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00301405
Brief Title
Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain
Official Title
Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Study closed. Difficult enrollment of patients with prostatitis.
Study Start Date
March 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Peters, MD
Collaborators
Celgene Corporation, William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis, Pelvic Pain
Keywords
prostatitis, pelvic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thalidomide
Arm Type
Active Comparator
Arm Description
Open Label drug
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Open label drug
Primary Outcome Measure Information:
Title
Decrease in pain as measured by visual analog scale

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
William Beaumont Hospital Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

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

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