Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Condition(s) targeted: Prostatitis

Intervention: Alfuzosin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
Leroy Nyberg, MD PhD, Study Director, Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
John Kusek, PhD, Study Director, Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

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

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

Primary outcome: NIH-CPSI Total Score

Secondary outcome:

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

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Stanford University Medical Center, Stanford, California 94305, United States

David Geffen School of Medicine at UCLA, Los Angeles, California 90095, United States

Northwestern U. Feinberg School of Medicine, Chicago, Illinois 60611, United States

University of Maryland, Baltimore, Maryland 21201, United States

Harvard Medical School- Massachusetts General Hospital, Boston, Massachusetts 02114, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

Queen's University, Kingston, Ontario K7L 3N6, Canada

Temple University, Philadelphia, Pennsylvania 19140, United States

University of Washington- Harborview Medical Center, Seattle, Washington 98108, United States

Related publications:

Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O'Leary MP, Pontari MA, McNaughton-Collins M, Shoskes DA, Comiter CV, Datta NS, Fowler JE Jr, Nadler RB, Zeitlin SI, Knauss JS, Wang Y, Kusek JW, Nyberg LM Jr, Litwin MS; Chronic Prostatitis Collaborative Research Network. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004 Oct 19;141(8):581-9.

Litwin MS. A review of the development and validation of the National Institutes of Health Chronic Prostatitis Symptom Index. Urology. 2002 Dec;60(6 Suppl):14-8; discussion 18-9. Review.

Schaeffer AJ; National Institute of Diabetes and Digestive and Kidney Diseases of the US National Institutes of Health. NIDDK-sponsored chronic prostatitis collaborative research network (CPCRN) 5-year data and treatment guidelines for bacterial prostatitis. Int J Antimicrob Agents. 2004 Sep;24 Suppl 1:S49-52.

Schaeffer AJ, Landis JR, Knauss JS, Propert KJ, Alexander RB, Litwin MS, Nickel JC, O'Leary MP, Nadler RB, Pontari MA, Shoskes DA, Zeitlin SI, Fowler JE Jr, Mazurick CA, Kishel L, Kusek JW, Nyberg LM; Chronic Prostatitis Collaborative Research Network Group. Demographic and clinical characteristics of men with chronic prostatitis: the national institutes of health chronic prostatitis cohort study. J Urol. 2002 Aug;168(2):593-8.

Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6.

Schaeffer AJ, Datta NS, Fowler JE Jr, Krieger JN, Litwin MS, Nadler RB, Nickel JC, Pontari MA, Shoskes DA, Zeitlin SI, Hart C; Chronic Prostatitis Collaborative Research Network. Overview summary statement. Diagnosis and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Urology. 2002 Dec;60(6 Suppl):1-4. Review.

Starting date: February 2005
Ending date: January 2008
Last updated: March 11, 2008