Official Title: “A Randomized Multicenter Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of 10mg Alfuzosin in the Treatment of Chronic Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS) in Recently-Diagnosed and/or Newly-Symptomatic Alpha-Blocker Naïve Patients”

The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH).

The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

The two primary objectives of this study are: - To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naïve CP/CPPS participants with respect to the primary endpoint in the NIH-CPSI. - To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants.

The proportion of "responders" in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo. Approximately 270 eligible patients, 135 per treatment arm, will be randomized and followed for a period of twelve (12) weeks after randomization. There will be four clinic visits.

Intervention(s) in this Clinical Trial

• Drug: Alfuzosin

Primary Measures

• NIH-CPSI Total Score

Secondary Measures

• Subscales of the NIH-CPSI
• Symptom Assessment Form
• Global Response Assessment
• McGill Pain Questionnaire
• Medical Outcomes Study Short Form 12
• Hospital Anxiety and Depression Scale
• International Index of Erectile Dysfunction
• Male Sexual Health Questionnaire

Inclusion Criteria:

• Participant has signed and dated the appropriate Informed Consent document.
• Participant is male.
• Participant is at least 18 years of age.
• Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.
• Symptoms bothersome enough to prompt a physician visit have been present for two years or less.

Exclusion Criteria:

• Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 CFU/ml in mid-stream urine (VB2).
• Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin HCL (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.
• Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.
• Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders.
• Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.
• Participant has uninvestigated, significant hematuria.
• Participant has undergone TURP, TUIP, TUIBN, TUMT, TUNA, balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
• Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
• Participant is currently taking exclusionary medications such as potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Overall Clinical Trial Officials and Contacts

Leroy Nyberg, MD PhD Study Director National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00103402

Study ID Number: cp/cpps

ClinicalTrials.gov Identifier: NCT00103402

Health Authority: United States: Food and Drug Administration