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

NCT00103402 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CPCRN2 AfluzosinRFA-DK-03-004U01DK065209
• Study Type: interventional
• Target: 272
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Prostatitis

Keywords

Prostatitis; Non-bacterial Prostatitis; Prostatodynia; Alfuzosin; Alpha-adrenergic blocker

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks

  For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI) total score, higher scores indicate more severe symptoms and scores range from 0 to 43. The primary outcome was a decline of at least 4 from baseline to 12 weeks

  Baseline and 12 weeks

Secondary Outcomes (7)

• Global Response Assessment (GRA)

  12 weeks

• Change in Subscales of the NIH-CPSI

  Baseline and12 weeks

• Change in Subscales of the McGill Pain Questionnaire

  Baseline and 12 weeks

• Change in Medical Outcomes Study Short Form 12

  Baseline and 12 weeks

• Change in Hospital Anxiety and Depression Scale

  Baseline and 12 weeks

Study Arms (2)

Alfuzosin

EXPERIMENTAL

10 mg of alfuzosin once daily for 12 weeks

Drug: Alfuzosin

Placebo

PLACEBO COMPARATOR

10 mg of an identical-looking placebo once daily for 12 weeks

Drug: Placebo

Interventions

Alfuzosin DRUG

Alfuzosin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).
• Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (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 transurethral prostatectomy (TURP), transurethral incision of the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• University of Pennsylvania: collaborator

Study Sites (10)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Northwestern U. Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Harvard Medical School- Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Washington- Harborview Medical Center

Seattle, Washington, 98108, United States

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (7)

• 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. doi: 10.7326/0003-4819-141-8-200410190-00005.

  PMID: 15492337 BACKGROUND

• 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. doi: 10.1016/s0090-4295(02)02296-3.

  PMID: 12521581 BACKGROUND

• 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. doi: 10.1016/j.ijantimicag.2004.02.009.

  PMID: 15364307 BACKGROUND

• 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.

  PMID: 12131316 BACKGROUND

• 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. doi: 10.1016/s0090-4295(02)01601-1.

  PMID: 12031372 BACKGROUND

• 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. doi: 10.1016/s0090-4295(02)01979-9.

  PMID: 12521576 BACKGROUND

• Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, Shoskes DA, Litwin MS, Alexander RB, White PC, Berger R, Nadler R, O'Leary M, Liong ML, Zeitlin S, Chuai S, Landis JR, Kusek JW, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008 Dec 18;359(25):2663-73. doi: 10.1056/NEJMoa0803240.

  PMID: 19092152 RESULT

MeSH Terms

Conditions

Prostatitis

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: J. Richard Landis, PhD
• Organization: University of Pennsylvania

hultman@upenn.edu

215-573-4922

Study Officials

• Leroy Nyberg, MD PhD

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

• John Kusek, PhD

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: February 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: June 12, 2020
• Results First Posted: June 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

US (9); CA (1)