Effects of Tomato-Soy Juice on Biomarkers in Patients With Prostate Cancer Undergoing Prostatectomy
Completed · Phase 1/Phase 2
Conditions studied: Prostate Cancer
In brief
RATIONALE: Tomato-soy juice may slow the growth of tumor cells. Studying samples of blood and tissue from patients with prostate cancer in the laboratory may help doctors identify biomarkers related to cancer. It may also help doctors understand the effect of tomato-soy juice on biomarkers. PURPOSE: This phase I/II trial is studying the side effects of tomato-soy juice and its effect on biomarkers in patients with prostate cancer undergoing prostatectomy.
Key facts
- Study ID
- NCT01009736
- Run by
- Ohio State University Comprehensive Cancer Center
- People needed
- 60
- Starts
- 2008-01-01
- Last updated by the study team
- 2014-10-16
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Biopsy proven carcinoma of the prostate.
- Have chosen radical prostatectomy (or cystoprostatectomy) for treatment of their disease after presented all possible options by medical team.
- Not receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- Not currently taking lycopene, soy dietary supplements, or "alternative" products (i.e. PC-SPES, Saw Palmetto).
- BUN/Cr (Blood urea nitrogen and serum creatinine), liver enzymes, CBC (complete blood count), and PT/PTT/INR (prothrombin time/partial thromboblastin time) within normal limits.
- Voluntarily agree to participate and a sign an informed consent document.
- Agree to have prostate biopsy blocks provided to the study for evaluation.
- Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study.
- Exclusion:
- Active malignancy other than prostate cancer that requires therapy.
- History of traumatic or surgical castration.
- History of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis.
- Are taking certain medications. No concurrent finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of BPH (benign prostate hyperplasia). Utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted. The use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products).
- Have certain medical conditions including: malabsorptive disorders or other metabolic disorders requiring special diet recommendations, severe constipation (may be accentuated by soy), a recent history of anemia or iron deficiency (possible accentuation by soy), or hypertension that requires a strict low sodium diet (tomato juice is high in sodium). The severity of these conditions and eligibility will be defined after careful review of the medical records by Dr. Clinton.
- Have a known allergy to soy or tomato components.
Where it is running
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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