Pharmacokinetic and Efficacy Study of Nordihydroguaiaretic Acid (NDGA) in Non Metastatic Recurrent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Nordihydroguaiaretic Acid (NDGA)
Intervention description: NDGA 2000mg daily
Intervention MeSH terms: Masoprocol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NDGA; Prostate Cancer

Summary:

      This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA
      administration and assessing the proportion of patients who experience a 50% decline in PSA.
    

Eligibility criteria:

        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:

               1. External beam radiotherapy with or without hormone therapy

               2. Brachytherapy with or without pelvic external beam radiation or hormone therapy

               3. 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:

               1. > 6 months since last day of effective androgen deprivation

               2. Testosterone > 250 ng/dL

               3. 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)