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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

This study is a phase II trial of NDGA in patients with hormone-sensitive non-metastatic
prostate cancer with a pharmacokinetics component. The first six patients enrolled will be
treated with a single 750 mg dose of oral NDGA on day -7 with measurement of pharmacokinetic
parameters over eight hours after the dose, then begin treatment with 2000 mg of oral NDGA
daily. Every four weeks, measurement of pharmacokinetic parameters at steady state will be
done for all patients. All patients will continue dosing with NDGA and will be followed for
PSA response and for safety. Measurement of pharmacokinetics for a 750 mg dose has been
chosen to evaluate levels with the dosage that patients will be taking at one time point
during the day (this is roughly one-third of the daily dose, which is administered in three
divided doses).

Inclusion Criteria:

- Rising 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

- 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 LHRH agonist or

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA Response

Outcome Time Frame:


Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

June 2011

Related Keywords:

  • Prostate Cancer
  • NDGA
  • Prostate Cancer
  • Prostatic Neoplasms



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115