Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer

NCT03665922 | Completed DMC

• 2 other identifiers: STUDY19050340R01CA225716
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether oral intake of a dietary supplement called BroccoMax®, which is a special blend of broccoli extract containing a chemical called sulforaphane (hereafter abbreviated as SFN), may result in changes in chemicals that feed prostate cancer. BroccoMax® is available over the counter.

Conditions

Prostate Cancer

Keywords

prostatectomy

Outcome Measures

Primary Outcomes (1)

• Palmitic Acid Reduction

  Change in serum levels of palmitic acid (the primary free fatty acid) in subjects treated with BroccoMax® compared to placebo.

  4 weeks

Secondary Outcomes (8)

• Evaluation of safety of BroccoMax® (side effects or adverse events)

  2 months

• Serum SFN levels

  4 weeks

• Urine SFN levels

  4 weeks

• Prostate adenocarcinoma SFN level

  Week 4

• Mean proliferative index (Ki-67) and apoptotic marker (TUNEL) in prostate adenocarcinoma sections

  Week 4

Study Arms (2)

BroccoMax®

EXPERIMENTAL

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.

Dietary Supplement: BroccoMax®

Placebo

PLACEBO COMPARATOR

Following randomization, subjects will begin to take four placebo tablets in the morning with breakfast and four tablets in the evening with dinner.

Other: Placebo

Interventions

BroccoMax® DIETARY_SUPPLEMENT

Nutraceutical neoadjuvant

BroccoMax®

Placebo OTHER

control

Also known as: Microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men ≥ 18 years of age scheduled to undergo radical prostatectomy as standard of care for a diagnosis of prostate adenocarcinoma.
• 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.
• 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
• Subjects willing to abstain from dietary sources of glucosinolates and isothiocyanates (see Appendix) for the duration of the study (4 weeks)
• 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

You may not qualify if:

• Subjects ineligible to undergo prostatectomy due to co-morbidities.
• 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.
• Subjects with malabsorption issues or gastrointestinal ailments than can interfere with the ability to adequately absorb SFN.
• Subjects with prior or concurrent androgen deprivation therapy with Luteinizing hormone-releasing hormone (LHRH) agonist or antagonists
• Subjects taking any other investigational agent, dietary supplement or herbal supplement or participating in clinical studies involving investigational agents
• 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.
• Subjects with prior history of known intolerance or allergic reactions attributed to cruciferous vegetables or specific fillers used in the placebo.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Shadyside Urology

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (10)

• 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.

  PMID: 28055103 BACKGROUND

• Key T. Risk factors for prostate cancer. Cancer Surv. 1995;23:63-77.

  PMID: 7621474 BACKGROUND

• 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.

  PMID: 23247693 BACKGROUND

• 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.

  PMID: 23123814 BACKGROUND

• 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.

  PMID: 26125442 BACKGROUND

• 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.

  PMID: 19748925 BACKGROUND

• 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.

  PMID: 21326325 BACKGROUND

• 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.

  PMID: 24691500 BACKGROUND

• 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.

  PMID: 27370570 BACKGROUND

• 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.

  PMID: 12824459 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bruce Jacobs, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ of P. Physicians Faculty

Model Details: Double-blind randomized placebo controlled design

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 11, 2018
• Study Start: May 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)