• Determine if Serenoa repens has a beneficial effect on subjective global assessment [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
• Assess impact of Serenoa repens over time using: BPH, QOL, Nocturia score, Peak uroflow, Post-void residual volume, PSA, Erectile/ejaculatory function, ICSmale Incontinence, Jenkins Sleep Dysfunction, and the NIH Chronic Prostatitis Symptom Index [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
• Assess the impact of the assigned treatments on complete blood counts and basic blood chemistries [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]

The CAMUS trial will test Saw palmetto in about 332 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills.

This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with BPH from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. Participants will be responsible for all other costs not associated with the study tests and medications. All information on study participants will be held in the strictest confidence and no one would have access to patient information other than the required authorized health care and research personnel.

The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic hyperplasia (BPH).

BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or at night. Men with BPH can also have a weak urine stream, a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a need to strain to get urination started. BPH is NOT the same as prostate cancer.

A number of natural products (extracts of different plants) seem to be able to reduce the bothersome symptoms of BPH with very few side effects over a few months. One of the plant extracts comes from the dwarf palm tree (Saw palmetto). We do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.

• Drug: Saw Palmetto

  Drug: Saw Palmetto

  REGIMEN: Participants will be randomized to one of the treatment arms:

  Serenoa repens 320 mg once daily for 24 weeks followed by Serenoa repens 640 mg once daily for 24 weeks followed by Serenoa repens 960 mg once daily for 24 weeks.

  Placebo for 72 weeks. DURATION: Participants will continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete 72 weeks of follow-up at the assigned treatment.

  SAMPLE SIZE: 350 participants randomized in a 1:1 allocation to Serenoa repens or placebo.

  Arms: 2 , 2

  Other Names:

  Serenoa repens (saw palmetto)

  Other Name: Serenoa repens (saw palmetto)
• Drug: Placebo
  matching placebo intervention
• Drug: Saw Palmetto

  Drug: Saw Palmetto

  REGIMEN: Participants will be randomized to one of the treatment arms:

  Serenoa repens 320 mg once daily for 24 weeks followed by Serenoa repens 640 mg once daily for 24 weeks followed by Serenoa repens 960 mg once daily for 24 weeks.

  Placebo for 72 weeks. DURATION: Participants will continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete 72 weeks of follow-up at the assigned treatment.

  SAMPLE SIZE: 350 participants randomized in a 1:1 allocation to Serenoa repens or placebo.

  Arms: 2 , 2

  Other Names:

  Serenoa repens (saw palmetto)

  Arms: 2

  Other Names:

  Serenoa repens (saw palmetto)

  Other Name: Serenoa repens

• 2: Placebo Comparator
  Treatment, Randomized, Double-blind, Placebo Controlled, Parallel Assignment, Efficacy Study
  Interventions:

  • Drug: Saw Palmetto
  • Drug: Placebo
• 1: Active Comparator
  Active and Placebo comparison
  Intervention: Drug: Saw Palmetto

Inclusion Criteria:

To be eligible for the study, potential participants must meet all of the following eligibility criteria:

1. Male at least 45 years of age.
2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.
3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits.
4. Voluntarily signed informed consent agreement prior to the performance of any study procedures.

Exclusion Criteria:

Potential participants that meet any of the following exclusion criteria will be excluded from the full-scale trial:

1. Any prior invasive intervention for BPH.
2. Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months.
3. Alpha blocker within one month.
4. Reported allergic reaction to Serenoa repens.
5. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma.
6. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months.
7. Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dl).
8. ALT (SGPT), AST (SGOT) or GGT value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement.
9. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement.
10. ECG reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome.
11. PSA level greater than 10 ng/ml at the first screening visit.
12. Requires the daily use of a pad or device for incontinence, or ICSmaleIS score >14 at screening.
13. Unstable medical condition within the past 3 months.
14. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction.
15. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery.
16. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
17. Documented bacterial prostatitis within the past year.
18. Two documented independent urinary tract infections of any type in the past year.
19. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin.
20. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not.
21. Unable to follow protocol directions due to organic brain or psychiatric disease.
22. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
23. Any serious medical condition likely to impede successful completion of the study.

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Cornell University
• New York University
• Kaiser Permanente
• Northwestern University
• Queen's University
• University of Colorado, Denver
• University of Iowa
• University of Maryland
• University of Texas
• Washington University School of Medicine
• Yale University