An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

• Sponsor: Kenneth Peters, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT00701311
• Collaborator: Celgene Corporation (Industry)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 33
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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. Likewise, no definitive therapy exists for CP/CPPS. We plan to study the use of CC-10004 in men with CP/CPPS.

Condition or Disease	Intervention/Treatment	Phase
Prostatitis; Chronic Prostatitis With Chronic Pelvic Pain Syndrome	Drug: CC-10004	Phase 2

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. Likewise, no definitive therapy exists for CP/CPPS. Unlike bacterial prostatitis, where a clear infecting organism can be determined, CP/CPPS is not always treated with antibiotics.

Due to the significant inflammatory nature of CP/CPPS, most prior therapies have focused on targeting the inflammation. CC-10004 in several studies has shown to be an inhibitor of inflammatory mediators, and may decrease the pain experienced from CP/CPPS.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Drug CC-10004 Study drug CC-10004 20mg taken orally twice a day.	Drug: CC-10004; CC-10004 20 mg per day

Outcome Measures

Primary Outcome Measures

1. Global Response Assessment [12 weeks]

   The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1. The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must be male aged ≥ 18 years at time of consent

• Must understand and voluntarily sign an informed consent form

• Male subjects with at least 3 months of symptoms of CP/CPPS (pain in the pelvic area, penis, scrotum, or perineum) who are refractory to other therapies (e.g. NSAIDS)

• Must be able to adhere to the study visit schedule and other protocol requirements

• Diagnosis of Chronic Prostatitis with a Chronic Prostatitis Symptom Index of at least 15/24

• Must meet the following laboratory criteria:

• Hemoglobin > 9 g/dL

• Hematocrit ≥ 27%

• White blood cell (WBC) count ≥ 3000 /mL (≥ 3.0 X 109/L) and < 20,000/mL (< 20 X 109/L)

• Platelets ≥ 100,000 /mL (≥ 100 X 109/L)

• Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)

• Total bilirubin £ 2.0 mg/dL

• Aspartate transaminase (AST) serum glutamic oxaloacetic transaminase (SGOT), and alanine transaminase (ALT) serum glutamate pyruvic transaminase,(SGPT), < 1.5x upper limit of normal (ULN)

• Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with female capable of becoming pregnant while on study medication and for 28 days after taking the last dose of study medication

Exclusion Criteria:

• Subjects who are female.

• Subjects with a documented positive urine culture within the past three months

• Subjects with duration of symptoms less than three months

• Subjects with genital infections within the past three months

• Subjects with clinical epididymitis within the past three months

• 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 with neutropenia (ANC < 750/ mm3)

• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study

• History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated.

• Positive Tuberculin skin test (Mantoux test)

• Clinically significant abnormality on the chest x-ray (CXR) at screening

• Any clinically significant abnormality on 12-lead ECG at screening

• Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)

• History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)

• Subjects currently taking chemotherapeutic agents

• Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening.

• Subjects with known history of significant disease as determined by the PI

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	William Beaumont Hospital	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• Kenneth Peters, MD
• Celgene Corporation

Investigators

• Principal Investigator: Kenneth Peters, MD, William Beaumont Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT00701311
• Other Study ID Numbers: 2007-135
• First Posted: Jun 19, 2008
• Last Update Posted: Oct 6, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals: Prostatitis; Pelvic pain
• Additional relevant MeSH terms: Prostatitis; Syndrome; Pelvic Pain; Chronic Disease; Somatoform Disorders; Apremilast

Study Results

Participant Flow

Recruitment Details	Recruitment took place over approximately one year from the offices of private urologists.
Pre-assignment Detail	A total of 21 male subjects meeting inclusion criteria were recruited. Of these, two failed screening and two were enrolled but did not start drug. Therefore 17 subjects started treatment drug.

Arm/Group Title	CC-10004
Arm/Group Description	CC-10004 administered 20mg po twice daily for up to 12 weeks.
Period Title: Overall Study
STARTED	17
COMPLETED	9
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	CC-10004
Arm/Group Description	CC-10004 administered 20mg po twice daily for up to 12 weeks.
Overall Participants	17
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.2 (10)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	17 100%
Region of Enrollment (participants) [Number]
United States	17 100%

Outcome Measures

1. Primary Outcome

Title	Global Response Assessment
Description	The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1. The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CC-10004
Arm/Group Description	CC-10004 administered 20mg po twice daily for up to 12 weeks.
Measure Participants	17
Number [participants]	2 11.8%

Adverse Events

Arm/Group Title	Treatment Arm
Arm/Group Description	Open label, one arm study.
All Cause Mortality
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Arm
	Affected / at Risk (%)	# Events
Total	12/17 (70.6%)
Gastrointestinal disorders
Nausea	3/17 (17.6%)
Diarrhea	2/17 (11.8%)
Nervous system disorders
Headache	2/17 (11.8%)
Dizziness	2/17 (11.8%)
Skin and subcutaneous tissue disorders
Lower extremity ulcer	1/17 (5.9%)
Mouth Ulcer	1/17 (5.9%)
Vascular disorders
Facial Flushing	1/17 (5.9%)

Limitations/Caveats

The limitation of this study is that only 9 of 17 participants completed full 12 weeks of treatment and there was no placebo arm.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.