ProstatitisPhase 2NCT00701311
An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A Phase 2 study testing CC-10004 in people with Prostatitis and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Kenneth Peters, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- What is being tested?
- CC-10004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
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.
Read the 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.
- Being tested
- CC-10004
- Keywords
- Prostatitis, Pelvic pain
- Medical subject headings
- Prostatitis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-10004Drug
CC-10004 20 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Study Drug CC-10004 | Experimental | Study drug CC-10004 20mg taken orally twice a day. Receives: Drug: CC-10004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Response Assessment
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701311
- Sponsor's protocol ID
- 2007-135
- Status last verified
- Sep 2014
- First submitted
- 18 Jun 2008
- Last updated
- 6 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT00701311
- Acronym / sponsor ID
- 2007-135
- Keywords
- Prostatitis, Pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jun 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 16 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Drug CC-10004 | Experimental | Drug: CC-10004Study drug CC-10004 20mg taken orally twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-10004CC-10004 20 mg per day | Drug | Study Drug CC-10004 |
Primary outcome
Global Response Assessment
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Prostatitis
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Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
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FOsfomycin for Male Urinary Tract Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Peters, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-10004 in people with Prostatitis and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by Kenneth Peters, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Response Assessment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014; AzTrials last refreshed its copy on 6 Nov 2026.