Chronic ProstatitisPhase 2NCT00301405
Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain
A Phase 2 study testing Thalidomide in people with Chronic Prostatitis and Pelvic Pain, run by Kenneth Peters, MD at 1 site in United States.
Trial summary
To determine the efficacy of thalidomide for treatment of the Chronic Pelvic Pain Syndrome (CPPS). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Prostatitis, Pelvic Pain
- What is being tested?
- Thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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 -
Who cannot join
- 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
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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 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
To determine the efficacy of thalidomide for treatment of the Chronic Pelvic Pain Syndrome (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 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.
- Conditions
- Chronic Prostatitis, Pelvic Pain
- Being tested
- Thalidomide
- Keywords
- prostatitis, pelvic pain
- Medical subject headings
- Pelvic Pain, Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Open label drug
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide | Active comparator | Open Label drug Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in pain as measured by visual analog scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2006
- Study completionNov 2006
Why it stopped: Study closed. Difficult enrollment of patients with prostatitis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Corewell Health East
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, William Beaumont Hospital Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301405
- Sponsor's protocol ID
- 2005-149 IND #74,062
- Status last verified
- Aug 2013
- First submitted
- 9 Mar 2006
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study of Thalidomide for Chronic Prostatitis/Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT00301405
- Acronym / sponsor ID
- 2005-149 IND #74,062
- Conditions
- Chronic Prostatitis, Pelvic Pain
- Keywords
- prostatitis, pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed. Difficult enrollment of patients with prostatitis.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Collaborators
- Celgene Corporation, Corewell Health East
- Study start
- Mar 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 10 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide | Active comparator | Drug: ThalidomideOpen Label drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| ThalidomideOpen label drug | Drug | Thalidomide |
Primary outcome
Decrease in pain as measured by visual analog scale
Results and safety
The study was stopped early (reason given: Study closed. Difficult enrollment of patients with prostatitis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
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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
William Beaumont Hospital Hospital
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 Thalidomide in people with Chronic Prostatitis and Pelvic Pain, 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 5 Aug 2013. 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?
The study was stopped early (reason given: Study closed. Difficult enrollment of patients with prostatitis.). Results are not available in the source record.
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?
Decrease in pain as measured by visual analog scale. 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 5 Aug 2013.