Saw Palmetto: Symptom Management for Men During Radiation Therapy

Lower urinary tract symptoms (LUTS) affect from 75-80% of men undergoing radiation therapy
(RT) for prostate cancer. The purpose of this study is to determine the feasibility, safety
and efficacy of an inexpensive, non-toxic herbal supplement, Saw Palmetto, in treating these
distressing symptoms.

This trial will use a two group randomized design: either placebo or 1 of 3 doses of Saw
Palmetto (320, 640, 960mg/day) to determine the maximum therapeutic dose (MTD), and obtain
preliminary evidence of efficacy. Within the Saw Palmetto arm, men will be allocated to 1 of
the 3 the doses using the Time-to-Event Continual Reassessment Method and will continue with
the same dose for the 12 week protocol.

Safety data will consist of the Common Terminology for Adverse Events criteria for nausea,
gastritis, and anorexia. Efficacy of the MTD will be evaluated by weekly symptom data and
voiding diary. A pill diary will be used to ensure intervention fidelity.

This study has the potential to reduce the incidence of LUTS for men during RT for cancer of
the prostate and ultimately improve their quality of life during the acute phase of
treatment.

Inclusion Criteria:

- Age 21 years or older

- Adenocarcinoma of the prostate

- Serum Prostate Specific Antigent (PSA) ≤ 40ng/ml

- Combined Gleason Score ≤ 8

- Karnofsky level of performance of > 70%

- Consented to undergo definitive Radiation Therapy

Exclusion Criteria:

- Stage T4 or M1

- Patient using own supply of Saw Palmetto or any other supplement containing the
following herbs: Pygeum (African Plum), Urtica Dioica (Stinging nettle), Cucurbita
peponis (pumpkin seed), PC-SPES (combination of 8 herbs), Beta-sitsterol (plant
sterols) or Cernilton (rye grass pollen).

- Prior pelvic radiation therapy

- Abnormality in liver and kidney function as evidenced by greater than twice the
normal values of Blood Urea Nitrogen (BUN), serum creatine, serum transaminases, and
alkaline phosphatase.

- Uncontrolled hypertension despite use of antihypertensive medication

- Presence of major psychiatric or medical illness (e.g., major cardiovascular events
within the previous 12 months)