Trial Information

Saw Palmetto Use During Radiation Therapy for Symptom Management Among Prostate Cancer Patients

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.