Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer
NCT ID: NCT03665922
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2019-05-01
2024-06-30
Brief Summary
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Detailed Description
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Baseline evaluation will be 28 days before scheduled prostatectomy, the same day of study drug dispensation, and will include.
1. Data collection on patient's medical history (which includes age, cancer history, review of medications, food intolerances and food habits), and concomitant medications.
2. Physical exam including height and weight measurements.
3. Blood (approximately 15 mL) will be collected in Serum Separator Tube-tiger tubes (SST)for determination of SFN and its metabolite levels and for biomarker analyses.
4. Spot urine collection (15 mL) for measuring SFN and its metabolite levels.
5. Four-week supply of study drug (BroccoMax® or Placebo) dispensation
Day 28 ± 3 days (End of study evaluation)
1. Physical exam including height and weight measurements
2. Blood (approximately 15 mL) will be collected in SST-tiger tubes for determination of SFN and its metabolite levels and for biomarker analyses.
3. Spot urine collection (15 mL) for measuring SFN and its metabolite levels.
4. Adverse event assessment.
5. A portion of the prostate tumor after surgical resection will be fresh frozen in liquid nitrogen.
6. After pathological assessment is complete, tumor blocks or slides (6 or more) will be requested by the clinical research coordinator from the Health Sciences Tissue Bank of the University of Pittsburgh for biomarker analyses.
Post-Treatment Follow-Up All study participants will have routine follow-up as determined by their treating urologist and/ or medical oncologist. This usually occurs 6 ± 2 weeks post-surgery and every 3 months thereafter. These are considered standard of care visits. The patient chart will be reviewed for their history and physical findings at these visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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BroccoMax®
Following randomization, subjects will begin to take four BroccoMax® tablets in the morning with breakfast and four tablets in the evening with dinner. The eight BroccoMax® tablets will provide a daily internal dose of 64 mg of SFN.
BroccoMax®
Nutraceutical neoadjuvant
Placebo
Following randomization, subjects will begin to take four placebo tablets in the morning with breakfast and four tablets in the evening with dinner.
Placebo
control
Interventions
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BroccoMax®
Nutraceutical neoadjuvant
Placebo
control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects willing to take oral placebo or BroccoMax® pills (4 capsules twice daily after breakfast and dinner) on a daily basis for 4 weeks prior to prostatectomy. Subjects have the ability to swallow BroccoMax® or placebo pills.
3. Subjects in good health per investigator evaluation with liver enzyme and blood count values within the following ranges:
White blood cells ≥ 3,000/mL Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN) Aspartate Aminotransferase (AST (SGOT))/ Alanine Aminotransferase (ALT (SGPT)) ≤ 2.5 x ULN Blood Urea Nitrogen (BUN) and serum creatinine ≤ 1.5 x ULN
4. Subjects willing to abstain from dietary sources of glucosinolates and isothiocyanates (see Appendix) for the duration of the study (4 weeks)
5. Subjects must be fully informed of the investigational nature of this study and must sign a written informed consent in accordance within institutional and regulatory guidelines
Exclusion Criteria
2. Subjects with a second malignancy or any other cancer at least 3 years following definitive treatment with no evidence of disease, except for adequately treated basal cell or squamous cell skin cancer.
3. Subjects with malabsorption issues or gastrointestinal ailments than can interfere with the ability to adequately absorb SFN.
4. Subjects with prior or concurrent androgen deprivation therapy with Luteinizing hormone-releasing hormone (LHRH) agonist or antagonists
5. Subjects taking any other investigational agent, dietary supplement or herbal supplement or participating in clinical studies involving investigational agents
6. Subjects with clinically significant comorbid diseases including active infection, uncontrolled angina, New York Heart Assoc. (NYHA) class III or IV heart failure, uncontrolled or uncontrollable hypertension, severe diabetes with complications, chronic liver disease.
7. Subjects with prior history of known intolerance or allergic reactions attributed to cruciferous vegetables or specific fillers used in the placebo.
18 Years
90 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Bruce Jacobs
Univ of P. Physicians Faculty
Principal Investigators
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Bruce Jacobs, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Shadyside Urology
Pittsburgh, Pennsylvania, United States
Countries
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References
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Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.
Key T. Risk factors for prostate cancer. Cancer Surv. 1995;23:63-77.
Roobol MJ, Carlsson SV. Risk stratification in prostate cancer screening. Nat Rev Urol. 2013 Jan;10(1):38-48. doi: 10.1038/nrurol.2012.225. Epub 2012 Dec 18.
Drudge-Coates L, Turner B. Prostate cancer overview. Part 2: metastatic prostate cancer. Br J Nurs. 2012 Oct 11-24;21(18):S23-4, S26-8.
Mitchell T, Neal DE. The genomic evolution of human prostate cancer. Br J Cancer. 2015 Jul 14;113(2):193-8. doi: 10.1038/bjc.2015.234. Epub 2015 Jun 30.
Ju J, Picinich SC, Yang Z, Zhao Y, Suh N, Kong AN, Yang CS. Cancer-preventive activities of tocopherols and tocotrienols. Carcinogenesis. 2010 Apr;31(4):533-42. doi: 10.1093/carcin/bgp205. Epub 2009 Sep 11.
Lee KW, Bode AM, Dong Z. Molecular targets of phytochemicals for cancer prevention. Nat Rev Cancer. 2011 Mar;11(3):211-8. doi: 10.1038/nrc3017. Epub 2011 Feb 10.
Saha A, Blando J, Silver E, Beltran L, Sessler J, DiGiovanni J. 6-Shogaol from dried ginger inhibits growth of prostate cancer cells both in vitro and in vivo through inhibition of STAT3 and NF-kappaB signaling. Cancer Prev Res (Phila). 2014 Jun;7(6):627-38. doi: 10.1158/1940-6207.CAPR-13-0420. Epub 2014 Apr 1.
Kallifatidis G, Hoy JJ, Lokeshwar BL. Bioactive natural products for chemoprevention and treatment of castration-resistant prostate cancer. Semin Cancer Biol. 2016 Oct;40-41:160-169. doi: 10.1016/j.semcancer.2016.06.003. Epub 2016 Jun 28.
Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24. doi: 10.1056/NEJMoa030660. Epub 2003 Jun 24.
Other Identifiers
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STUDY19050340
Identifier Type: -
Identifier Source: org_study_id
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