A Randomized Phase II Dose Finding Study of ArginMax for Its Effect on Erectile Function and Quality of Life in Survivors of Prostate Cancer Previously Treated With Radiotherapy
- To determine the "best dose" (defined as the dose that shows the greatest improvement
in the erectile function domain of the International Index of Erectile Function [IIEF]
after 8 weeks of therapy) of an L-arginine/Korean ginseng/gingko biloba/damiana-based
supplement (L-arginine) to be used in a subsequent phase III trial in prostate cancer
survivors previously treated with radiotherapy.
- Evaluate the toxicity of treatment with L-arginine with or without phosphodiesterase-5
- Estimate trial accrual, retention, adherence, and variability.
- Assess changes in quality of life (QOL) and sexual function as defined by changes in
the QOL of these patients using the Expanded Prostate Cancer Index Composite, changes
in the other domains of the IIEF (i.e., orgasmic function, sexual desire, intercourse
satisfaction, and overall satisfaction), changes in the Sexual Encounter Profile, and
changes in the percentage of "yes" (positive) responses to either of the two global
OUTLINE: Patients are stratified according to age (< 65 years vs ≥ 65 years) and current use
of phosphodiesterase-5 (PDE-5) inhibitors (yes vs no). Patients are randomized to 1 of 3
- Arm I: Patients receive oral placebo twice daily (total of 6 capsules per day).
- Arm II: Patients receive oral L-arginine and oral placebo twice daily (total of 3
capsules of each per day).
- Arm III: Patients receive oral L-arginine twice daily (total of 6 capsules per day).
In all arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.
Patients may also receive oral sildenafil, tadalafil, or vardenafil (PDE-5 inhibitors).
Patients complete the International Index of Erectile Function and the Expanded Prostate
Cancer Index Composite-26 at baseline and at weeks 4 and 8. Patients also complete the
Sexual Encounter Profile Questionnaire, FACT-P, and the Global Efficacy Questionnaire at
weeks 4 and 8.
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Determine the best dose of ArginMax
The best dose will be defined as the one that results in the greatest improvement in erectile function.
James J. Urbanic, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
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