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.

Condition	Treatment or Intervention	Phase
Prostatitis	Drug: Alfuzosin	Phase III

Further Study Details: 

Primary Outcomes: 4-point decrease from baseline to 12 weeks in the NIH-CPSI Total Score
Secondary Outcomes: 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
Expected Total Enrollment:  270

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 primary endpoint to be used for efficacy evaluation is the response rate, defined as a 4-point decrease from baseline to 12 weeks in the NIH-CPSI Total Score (scale of 0 - 43). 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

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.

California
      Stanford University Medical Center, Stanford,  California,  94305,  United States; Recruiting
      David Geffen School of Medicine at UCLA, Los Angeles,  California,  90095,  United States; Recruiting
Illinois
      Northwestern U. Feinberg School of Medicine, Chicago,  Illinois,  60611,  United States; Recruiting
Maryland
      University of Maryland, Baltimore,  Maryland,  21201,  United States; Recruiting
Massachusetts
      Harvard Medical School- Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216,  United States; Recruiting
Pennsylvania
      Temple University, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
Washington
      University of Washington School of Medicine, Seattle,  Washington,  98195,  United States; Recruiting
      University of Washington- Harborview Medical Center, Seattle,  Washington,  98108,  United States; Recruiting
Canada, Ontario
      Queen's University, Kingston,  Ontario,  K7L 3N6,  Canada; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  cp/cpps; RFA-DK-03-004
Record last reviewed:  February 2005
Last Updated:  February 11, 2005
Record first received:  February 7, 2005
ClinicalTrials.gov Identifier:  NCT00103402
Health Authority: United States: Food and Drug Administration; Canada: Health Canada (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08