This proposal is one of 12, one for each of the 11 clinical centers plus one for the Data Coordinating Center (DCC), relevant to the continued funding of NIDDK's CAMUS clinical trial that is investigating the efficacy and safety of an extract of the berries of Serenoa repens (saw palmetto) for the treatment of benign prostrate hyperplasia (BPH). Each of the 12 proposals includes a common section prepared under the purview of the study's Steering Committee, followed by a section specific to the center submitting the application. This specific application is for the Clinical Center at the Queen's University at Kingston, Ontario Canada. Details for this center begin on page following the common section below. The overall CAMUS trial (Complementary and Alternative Medicine for Urological Symptoms) is fully functional and well underway. Funded jointly by NIDDK, the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS), it has successfully randomized 369 participants, more than the 350 initially targeted;however, recruitment took longer than the six months initially expected so that the protocol specified treatment period for the last participants recruited now extends beyond the current funding period which ends March 31, 2010. The first participant is scheduled to complete follow-up in December, 2009 and the last in October, 2010. As a consequence, funding is requested for an additional period to permit ail CAMUS subjects to complete the 72 weeks of follow-up specified in the protocol and to allow for appropriate data clean up, analyses and publications. CAMUS is a randomized, double-blind, two arm trial with 369 participants, approximately equally allocated to either the Serenoa repens extract or placebo in escalating doses over three consecutive 24 weeks periods, beginning with 320 mg, then 640 mg, then and then 960 mg daily. Participants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 week treatment period. The 11 CAMUS clinical centers initiated recruitment June 5, 2008 and successfully completed randomization of 369 subjects on April 17, 2009.

Public Health Relevance

Statement not given.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK063797-07
Application #
7990688
Study Section
Special Emphasis Panel (ZDK1-GRB-R (M2))
Program Officer
Kusek, John W
Project Start
2003-09-30
Project End
2011-06-30
Budget Start
2010-09-20
Budget End
2011-06-30
Support Year
7
Fiscal Year
2010
Total Cost
$72,450
Indirect Cost
Name
Queen's University at Kingston
Department
Type
DUNS #
207884032
City
Kingston
State
ON
Country
Canada
Zip Code
K7 3-N6
Lee, Jeannette Y; Moore, Page; Kusek, John et al. (2014) Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto. J Altern Complement Med 20:48-52
Barry, Michael J; Cantor, Alan; Roehrborn, Claus G et al. (2013) Relationships among participant international prostate symptom score, benign prostatic hyperplasia impact index changes and global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms. J Urol 189:987-92
Andriole, Gerald L; McCullum-Hill, Christie; Sandhu, Gurdarshan S et al. (2013) The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial. J Urol 189:486-92
Helfand, Brian T; Lee, Jeanette Y; Sharp, Victoria et al. (2012) Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol 188:2288-93
Barry, Michael J; Avins, Andrew L; Meleth, Sreelatha et al. (2011) Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology 78:550-4
Barry, Michael J; Meleth, Sreelatha; Lee, Jeannette Y et al. (2011) Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA 306:1344-51
Helfand, Brian T; McVary, Kevin T; Meleth, Sreelatha et al. (2011) The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol 185:2223-8
Lee, Jeannette Y; Foster Jr, Harris E; McVary, Kevin T et al. (2011) Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med 17:469-72
Lee, Jeannette; Andriole, Gerald; Avins, Andrew et al. (2009) Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials 6:628-36
Nickel, J Curtis; Roehrborn, Claus G; O'Leary, Michael P et al. (2008) The relationship between prostate inflammation and lower urinary tract symptoms: examination of baseline data from the REDUCE trial. Eur Urol 54:1379-84

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