L-Arginine Supplementation With or Without Enzyme Inhibitors Treating Erectile Function of Prostate Cancer Survivors
Condition: Male Erectile Disorder; Prostate Cancer; Radiation Toxicity
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Intervention: Placebo; Oral L-Arginine; Oral L-Arginine
Intervention description: Given orally; Given orally 3 capsules ArginMax and 3 Placebo capsules; Patients will take 6 capsules of ArginMax twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiation toxicity; male erectile disorder; prostate cancer

Summary:

      RATIONALE: L-arginine supplements may improve the quality of life and erectile function in
      men who are prostate cancer survivors.

      PURPOSE: This randomized phase II trial is studying how well L-arginine supplementation works
      with or without enzyme inhibitors in treating erectile function and quality of life of
      prostate cancer survivors previously treated with radiation therapy.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Male prostate cancer survivor previously treated with radiotherapy and who identifies
             himself as concerned with sexual quality of life, including erectile dysfunction.
             (seed implants are eligible)

          -  Had successful sexual activity prior to the commencement of radiotherapy.

          -  Erectile dysfunction, defined as inability to achieve or maintain an erection
             sufficient for satisfactory sexual performance

          -  Interested in sexual activity and agrees to make at least one sexual intercourse
             attempt with a partner every week during the study.

          -  The usage of PDE-5 inhibitors will be voluntary and will serve as a stratification
             factor. Patients taking PDE-5 inhibitors must agree to assume the responsibility for
             the cost of PDE-5 inhibitor treatment during the protocol period (8 week period) as
             this is not covered in the cost of the trial.

          -  Patients currently taking PDE-5 inhibitors sildenafil (Viagra®, Pfizer
             Pharmaceuticals), tadalafil(Cialis®, Lilly ICOS, LLC), and vardenafil (Levitra®, Bayer
             Healthcare / Schering Plough Corp.)must agree to take the medication only as
             prescribed by their treating physician.

          -  Patients taking PDE-5 inhibitors as part of this study must be on a stable dose of
             drug for at least one month prior to study entry.

          -  Must be able to take oral medications.

          -  > 6 months following completion of all cancer therapy

          -  No evidence of prostate cancer

          -  Prior malignancies allowed if no evidence of recurrent disease.

          -  If previously taken LHRH agonist androgen suppression (e.g, Lupron, Zoladex),
             anti-androgen (e.g., Casodex, Eulexin, Nilandron), or estrogenic (e.g.,
             diethylstilbestrol) agents, serum testosterone must have returned to the laboratory
             normal range

          -  No planned surgery while on protocol or for 4 weeks following completion of protocol

          -  Prior cystoscopy is permitted.

          -  Age > 18

          -  ECOG performance status 0/1.

          -  Patients must agree not to start taking an herbal product for erectile dysfunction
             during the eight weeks of study intervention.

        EXCLUSION CRITERIA:

          -  No other concurrent erectile dysfunction therapies permitted (i.e. vacuum
             pump,cavernosal injections, and other drug therapies). Past use of these and other
             therapies permitted if the patient can meet the inclusion criteria above.

          -  No testosterone supplementation permitted.

          -  Use of LHRH agonist androgen suppression (e.g, Lupron, Zoladex), anti- androgen (e.g.,
             Casodex,Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents within
             the last 6 months.

          -  Prior prostate or lower genitourinary surgery (bladder, penis, urethra,
             testicles)including transurethral resection of prostate (TURP). (Prior vasectomy is
             allowed)

          -  Serious cardiovascular disease (unstable angina, supraventricular arrhythmia,
             myocardial infarction, symptomatic congestive heart failure, cardiac arrhythmia,
             coronary artery bypass surgery within 6 months prior to registration).

          -  Hypotension (<90/50mm Hg), or uncontrolled hypertension (>170/100 mm Hg)

          -  Stroke or spinal cord injury within 6 months before registration.

          -  Patients on Persantine, heparin, Lovenox, warfarin, ginkgo biloba, Plavix, Disalcid,
             other blood-thinning medication or with a history of bleeding disorders will be
             excluded.(Aspirin < 325mg allowed)

          -  Current use of cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir.
             Major medical or psychiatric illness which, in the opinion of the investigator, would
             prevent completion of treatment or would interfere with follow-up.

          -  Current or prior use of any organic nitrate within the last 6 months (e.g., use of
             nitroglycerin)

          -  May not receive other investigational agents or devices during 30 days prior to start
             of study drug.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ArginMax (l-arginine, ginseng, or ginkgo biloba)