Saw Palmetto: Symptom Management for Men During Radiation Therapy

• Feasibility [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  Assess a Saw Palmetto supplementation protocol for feasibility by evaluation if at least 70% of eligible men consent, and if at least 70% of men enrolled at each dose complete the study.
• Efficacy [ Time Frame: Baseline to Week 22 ] [ Designated as safety issue: No ]
  Evaluate preliminary efficacy of Saw Palmetto at the MTD as compared to the placebo group with respect to Health Related Quality of life (HRQOL) including physical functioning.
• Safety [ Time Frame: Baseline to Week 22 ] [ Designated as safety issue: Yes ]
  Establishing the maximum tolerated dose (MTD) among 320mg, 640mg,or 960mg, at which less than 10% of men report less than a grade 2 of gastrointestinal symptoms. Also, by comparing PSA and blood chemistry levels at 6 weeks and post-Saw Palmetto treatment to the corresponding levels in the placebo group.

The aim of this study is to test whether Saw Palmetto, is useful in preventing or reducing the side effects for men undergoing radiation therapy for prostate cancer. Urinary symptoms will be recorded each week, as well as assessment of quality of life through: 1) Physical Well-Being 2) Social/Family Well-being 3) Emotional Well-Being, and 4) Functional Well-Being.

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.

• Active Comparator: Saw Palmetto Soft Gel
  Intervention: Drug: Saw Palmetto
• Placebo Comparator: Soybean Oil Soft Gel
  Intervention: Drug: Saw Palmetto

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)