Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer

Inclusion Criteria:

Rising prostate-specific antigen (PSA) value after local therapy with a PSA doubling time (PSADT) between 6 and 24 months (four or more readings at least two weeks apart within the last six months)

Prior definitive therapy for prostate cancer consisting of one of the following:

External beam radiotherapy with or without hormone therapy
Brachytherapy with or without pelvic external beam radiation or hormone therapy
Radical prostatectomy with or without adjuvant or salvage radiation therapy
PSA > 1 ng/ml, which has risen serially on two determinations at least one week apart
Progressive disease by "Phoenix" consensus definition for patients who have undergone primary radiation therapy (PSA nadir + 2 ng/mL)
No metastatic disease

Prior adjuvant or neoadjuvant androgen deprivation is permitted, provided:

> 6 months since last day of effective androgen deprivation
Testosterone > 250 ng/dL
Patient is not on intermittent androgen deprivation
Karnofsky performance status (KPS) of > 70%
Liver Function Tests are within normal range
Glycated hemoglobin (HgA1c) < 6%
Patients must be four weeks from major surgery or radiotherapy to be eligible

Exclusion Criteria:

Presence of another active malignancy other than prostate cancer, or treated squamous/basal cell carcinoma of the skin. Concomitant medical condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements
Diabetes mellitus, unless diet-controlled
Must be off saw palmetto, pomegranate juice, finasteride, or any herbal agent intended to lower PSA for > 4 weeks. Baseline PSADT calculation must occur off of these agents
Patients may not have evidence of local-only recurrence of prostate cancer
No history of liver disease, including Hepatitis B or C, alcoholic liver disease, or autoimmune liver disease. A prior history of Hepatitis A is allowed provided that baseline liver function tests are within normal limits
Patients with castration resistant prostate cancer are ineligible (prostate cancer which has progressed on androgen deprivation therapy with a Luteinizing hormone-releasing hormone (LHRH)-agonist or orchiectomy)