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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA225716 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
Eligible subjects will be randomly assigned to either BroccoMax® or placebo arm with a 1:1 randomization. Each subject will be given BroccoMax® equivalent to 4 weeks supply. Following randomization, subjects will begin to take four study tablets (BroccoMax® or placebo) 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.
Baseline evaluation will be 28 days before scheduled prostatectomy, the same day of study drug dispensation, and will include.
Day 28 ± 3 days (End of study evaluation)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BroccoMax® | Dietary Supplement | Nutraceutical neoadjuvant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety of BroccoMax® (side effects or adverse events) | Assessing any side effects or adverse events that could be associated with the oral intake of BroccoMax® | 2 months |
| Serum SFN levels |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Jacobs, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shadyside Urology | Pittsburgh | Pennsylvania | 15232 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 1, 2025 | |
| Reset | Jul 22, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 1, 2025 | Jul 22, 2025 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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Double-blind randomized placebo controlled design
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| Placebo |
| Other |
control |
|
|
Compare the levels of SFN and its metabolites in serum at day 14 and week 4 to baseline
| 4 weeks |
| Urine SFN levels | Compare the levels of SFN and its metabolites in urine at day 14 and week 4 to baseline. | 4 weeks |
| Prostate adenocarcinoma SFN level | Evaluate the SFN and its metabolites in the prostate/ prostate adenocarcinoma tissue. | Week 4 |
| Mean proliferative index (Ki-67) and apoptotic marker (TUNEL) in prostate adenocarcinoma sections | Evaluate the biomarkers of the collected tissue. | Week 4 |
| Evaluation of Prostate adenocarcinoma tissue by immunohistochemistry. | Prostate adenocarcinoma expression of acetyl-Coenzyme A carboxylase 1 (ACC1), fatty acid synthase (FASN), carnitine palmitoyltransferase1A (CPT1A), androgen receptor (AR), phosphatase and tensin homolog (PTEN), sterol regulatory binding protein 1 (SREBP-1) and c-Myc by immunohistochemistry (IHC) | Week 4 |
| Evaluation of serum levels of fatty acid metabolism intermediates. | Evaluate Serum levels of Acetyl-Coenzyme A, Malonyl-Coenzyme A, total phospholipids, adenosine triphosphate (ATP), and global lipidemic | Weeks 2 and 4. |
| Evaluation of prostate adenocarcinoma levels of fatty acid metabolism intermediates | Evaluate prostate adenocarcinoma levels of Acetyl-Coenzyme A, Malonyl-Coenzyme A, total phospholipids, ATP, and global lipidemic | Week 4 |
| 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. |
| 23123814 | 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. |
| 26125442 | 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. |
| 19748925 | 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. |
| 21326325 | 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. |
| 24691500 | 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. |
| 27370570 | 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. |
| 12824459 | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |