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

• Status: Terminated
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kenneth Peters, MD
• Collaborators: Celgene Corporation; William Beaumont Hospitals
• Treatments: Thalidomide

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.