Benign prostatic hypertrophy or (BPH) is the gradual enlargement of the prostate which occurs in most men as they age. This seems to be a natural process and is very common affecting over 10 million American men; half of all men over the age of 50 and nearly 80% of men over the age of 70. Why the prostate starts to enlarge is not specifically known but is thought to be related to the effect of male hormones, including testosterone, on the aging gland. Family history of prostate enlargement can also increase the odds of developing BPH.

The major symptom of enlargement of the prostate is the need to pass urine frequently, with frequency increasing as time goes on. A man may find himself rising several times during the night to urinate. There can also be pain, burning and difficulty in starting and stopping urination. The presence of blood in the urine is not uncommon. Some dribbling is very common, as well. The afore mentioned effects of BPH can be very troublesome, and ultimately lead to a lower quality of life. Thankfully, new treatments are becoming available to help fight BPH!

The Grampsas Center for Urologic Oncology at the University of Colorado Cancer Center (UCCC)offers patients cutting-edge clinical studies in the fight against BPH. Ongoing enrollment is currently happening for a number of different clinical research studies. An example one such trial is outlined below:

Do You Have Any of These Urinary Symptoms?

· straining or waiting for the stream to start,

· sensation of not emptying your bladder completely,

· getting up multiple times during the night to urinate,

· slow, weak, or interrupted urinary stream,

· increased frequency or urgency of urination.

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Principal Investigator: E. David Crawford, MD
COMIRB Protocol Number: 07-0118
Aeterna Zentaris (D-20762-Z033)

Purpose of This Research

Dr. Crawford and other physicians at the University of Colorado at Denver and Health Sciences Center are conducting a research study to determine whether an investiga­tional injectable drug can help reduce unpleasant urinary symptoms caused by a type of enlarged prostate known as benign prostatic hyperplasia or BPH.

Who Can Take Part

To be eligible for this study, you must:

· be 50 years of age or older,

· not have had surgery for your prostate or bladder,

· not have another cause for your urinary symptoms (such as urinary tract disease or infection, or neurological problems,

· have a prostate specific antigen (PSA) level less than 10 ng/ml, and

· be able to complete the study in the opinion of the investigator.

Cost to Patient

All study-related clinic visits, laboratory tests, and medical procedures will be covered for qualified participants except for the initial physician visit, the physician follow-up visit at 52 weeks (one year), and the final physician study follow-up visit at 90 weeks. These three visits are considered routine care for treating men with enlarged prostates, and will, therefore, be billed to you or your insurance company. Study medication will be provided at no cost.