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A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer

Phase 1
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase I Study of NDGA in Patients With Non-Metastatic Biochemically Relapsed Prostate Cancer



- Determine the maximum tolerated dose of nordihydroguaiaretic acid (NDGA) in patients
with nonmetastatic, biochemically relapsed prostate cancer.


- Determine prostate-specific antigen-modulating effects of NDGA in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral nordihydroguaiaretic acid (NDGA) twice daily on days 1-28. Treatment
repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of NDGA until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed prostate cancer, meeting 1 of the following criteria:

- Androgen-dependent disease (testosterone ≥ 250 ng/mL)

- Androgen-independent disease (testosterone < 50 ng/mL)

- Received prior definitive therapy for primary prostate cancer comprising any of the

- External-beam radiotherapy with or without hormonal therapy

- Brachytherapy with or without pelvic external-beam radiotherapy or hormonal

- Radical prostatectomy with or without adjuvant or salvage radiotherapy

- Cryotherapy

- Must have evidence of disease progression, as evidenced by elevated prostate-specific
antigen (PSA) that has risen serially from post-definitive therapy nadir on 2
determinations taken ≥ 1 week apart

- Elevated PSA, meeting 1 of the following criteria:

- At least 1.0 ng/mL post radiotherapy or cryotherapy

- At least 4 ng/mL post radical prostatectomy

- Must show disease progression after discontinuation of the antiandrogen (for
patients with androgen-dependent disease receiving antiandrogen as part of
primary androgen ablation)

- No metastatic disease, confirmed by negative bone scan and negative CT scan or MRI of


- Karnofsky performance status 70-100%

- Absolute neutrophil count ≥ 1,500/mm³

- Hemoglobin ≥ 8.0 g/dL

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- AST ≤ 1.5 times ULN

- No other medical condition that would interfere with study therapy or compliance

- No other active malignancy except previously treated squamous cell or basal cell skin
cancer or cancer that has been treated and considered to be at < 30% risk of relapse

- Fertile patients must use effective contraception


- See Disease Characteristics

- More than 8 weeks since prior strontium-chloride Sr 89

- More than 4 weeks since first dose of bisphosphonates

- More than 4 weeks since prior major surgery or radiotherapy

- At least 4 weeks since prior hormonal agents, including megestrol or steroids

- Concurrent luteinizing hormone-releasing hormone analogs allowed to maintain
castrate levels of testosterone

- At least 4 weeks since prior and no concurrent saw palmetto, finasteride, or any
herbal agent intended to lower PSA

- Prior adjuvant or neoadjuvant androgen-deprivation therapy allowed for
androgen-dependent prostate cancer provided that all of the following are met:

- No more than 8 months of androgen deprivation

- At least 12 months since last day of effective androgen deprivation

- Testosterone > 250 ng/mL at enrollment

- Prior hormonal therapy, chemotherapy, or investigational therapy for biochemical
relapse allowed

- No concurrent chemotherapeutic, immunotherapeutic, or other investigational agents

- No concurrent radiotherapy

- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity as measured by CTC v3.0

Safety Issue:


Principal Investigator

Charles Ryan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

June 2005

Completion Date:

October 2006

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage I prostate cancer
  • Prostatic Neoplasms



UCSF Comprehensive Cancer Center San Francisco, California  94115