Nordihydroguaiaretic Acid in Treating Patients With Nonmetastatic Relapsed Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage I prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 following: External-beam radiotherapy with or without hormonal therapy Brachytherapy with or without pelvic external-beam radiotherapy or hormonal therapy 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 abdomen/pelvis PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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)
Sites / Locations
- UCSF Comprehensive Cancer Center