Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA

NCT01681823 | Completed Phase 2 DMC

• 1 other identifier: MMC12192-12CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if the oral administration of PectaSol-C Modified Citrus Pectin (MCP) is effective at improving Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels. Also, documentation of any side effects or benefits within parameter of the study is included.

Conditions

Prostatic Neoplasms

Keywords

Prostate Cancer; Prostatic Neoplasms; Prostate Specific Antigen; Modified Citrus Pectin; PectaSol-C; Biochemical Relapse

Outcome Measures

Primary Outcomes (1)

• Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels.

  PSA doubling time increase will be used to show effectiveness of the Modified Citrus pectin (MCP).

  6 month endpoint.

Secondary Outcomes (1)

• An assessment of adverse side effects due to Modified Citrus Pectin (MCP).

  6 month endpoint.

Other Outcomes (1)

• Blood Serum Analysis (Galectin-3, C-Reactive Protein, Lipid Panels)

  6 month endpoint.

Study Arms (1)

PectaSol-C Modified Citrus Pectin (MCP)

EXPERIMENTAL

Treatment with 4.8 grams PectaSol-C Modified Citrus Pectin three times a day, away from meals for six months.

Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)

Interventions

PectaSol-C Modified Citrus Pectin (MCP) DIETARY_SUPPLEMENT

Oral administration of PectaSol-C MCP (4.8 grams in six capsules three times a day away from food).

PectaSol-C Modified Citrus Pectin (MCP)

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented PC post local therapy with undetectable Prostate Specific Antigen (PSA), and biochemical relapse (defined as post-surgery PSA \> 0.2 ng/ml; post-radiation \> nadir +2 ng/ml, the PSA nadir is the lowest PSA reading achieved after treatment), with linear progression of at least 3 PSA tests in at least 3 months before the commencement of the trial.
• All patients must have negative bone scan and CT scan for the chest-abdomen-pelvis within 2 weeks prior to study initiation.

You may not qualify if:

• Psychological, familial, sociological or geographical conditions that may interfere with compliance with the study or prevent completion or compliance of protocol.
• Other severe or poorly controlled medical condition(s).
• Known allergies to any of the ingredients.
• Hormonal therapy or other therapy for PC in the last 3 months.
• Positive bone scan or CT scan of the chest-abdomen-pelvis.

Sponsors & Collaborators

• EcoNugenics: lead

Study Sites (1)

Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59,

Kfar Saba, Israel

Location

Related Publications (25)

• Keizman D, Maimon N, Gottfried M. Metastatic hormone refractory prostate cancer: recent advances in standard treatment paradigm, and future directions. Am J Clin Oncol. 2014 Jun;37(3):289-96. doi: 10.1097/COC.0b013e318248dc1e.

  PMID: 22772426 BACKGROUND

• Antonarakis ES, Zahurak ML, Lin J, Keizman D, Carducci MA, Eisenberger MA. Changes in PSA kinetics predict metastasis- free survival in men with PSA-recurrent prostate cancer treated with nonhormonal agents: combined analysis of 4 phase II trials. Cancer. 2012 Mar 15;118(6):1533-42. doi: 10.1002/cncr.26437.

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• Nangia-Makker P, Conklin J, Hogan V, Raz A. Carbohydrate-binding proteins in cancer, and their ligands as therapeutic agents. Trends Mol Med. 2002 Apr;8(4):187-92. doi: 10.1016/s1471-4914(02)02295-5.

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• Yan J, Katz A. PectaSol-C modified citrus pectin induces apoptosis and inhibition of proliferation in human and mouse androgen-dependent and- independent prostate cancer cells. Integr Cancer Ther. 2010 Jun;9(2):197-203. doi: 10.1177/1534735410369672. Epub 2010 May 11.

  PMID: 20462856 BACKGROUND

• Kolatsi-Joannou M, Price KL, Winyard PJ, Long DA. Modified citrus pectin reduces galectin-3 expression and disease severity in experimental acute kidney injury. PLoS One. 2011 Apr 8;6(4):e18683. doi: 10.1371/journal.pone.0018683.

  PMID: 21494626 BACKGROUND

• Ramachandran C, Wilk BJ, Hotchkiss A, Chau H, Eliaz I, Melnick SJ. Activation of human T-helper/inducer cell, T-cytotoxic cell, B-cell, and natural killer (NK)-cells and induction of natural killer cell activity against K562 chronic myeloid leukemia cells with modified citrus pectin. BMC Complement Altern Med. 2011 Aug 4;11:59. doi: 10.1186/1472-6882-11-59.

  PMID: 21816083 BACKGROUND

• Jiang J, Eliaz I, Sliva D. Synergistic and additive effects of modified citrus pectin with two polybotanical compounds, in the suppression of invasive behavior of human breast and prostate cancer cells. Integr Cancer Ther. 2013 Mar;12(2):145-52. doi: 10.1177/1534735412442369. Epub 2012 Apr 24.

  PMID: 22532035 BACKGROUND

• Liu HY, Huang ZL, Yang GH, Lu WQ, Yu NR. Inhibitory effect of modified citrus pectin on liver metastases in a mouse colon cancer model. World J Gastroenterol. 2008 Dec 28;14(48):7386-91. doi: 10.3748/wjg.14.7386.

  PMID: 19109874 BACKGROUND

• Glinsky VV, Raz A. Modified citrus pectin anti-metastatic properties: one bullet, multiple targets. Carbohydr Res. 2009 Sep 28;344(14):1788-91. doi: 10.1016/j.carres.2008.08.038. Epub 2008 Sep 26.

  PMID: 19061992 BACKGROUND

• Zhao ZY, Liang L, Fan X, Yu Z, Hotchkiss AT, Wilk BJ, Eliaz I. The role of modified citrus pectin as an effective chelator of lead in children hospitalized with toxic lead levels. Altern Ther Health Med. 2008 Jul-Aug;14(4):34-8.

  PMID: 18616067 BACKGROUND

• Eliaz I, Weil E, Wilk B. Integrative medicine and the role of modified citrus pectin/alginates in heavy metal chelation and detoxification--five case reports. Forsch Komplementmed. 2007 Dec;14(6):358-64. doi: 10.1159/000109829. Epub 2007 Dec 12.

  PMID: 18219211 BACKGROUND

• Johnson KD, Glinskii OV, Mossine VV, Turk JR, Mawhinney TP, Anthony DC, Henry CJ, Huxley VH, Glinsky GV, Pienta KJ, Raz A, Glinsky VV. Galectin-3 as a potential therapeutic target in tumors arising from malignant endothelia. Neoplasia. 2007 Aug;9(8):662-70. doi: 10.1593/neo.07433.

  PMID: 17786185 BACKGROUND

• Eliaz I, Hotchkiss AT, Fishman ML, Rode D. The effect of modified citrus pectin on urinary excretion of toxic elements. Phytother Res. 2006 Oct;20(10):859-64. doi: 10.1002/ptr.1953.

  PMID: 16835878 BACKGROUND

• Guess BW, Scholz MC, Strum SB, Lam RY, Johnson HJ, Jennrich RI. Modified citrus pectin (MCP) increases the prostate-specific antigen doubling time in men with prostate cancer: a phase II pilot study. Prostate Cancer Prostatic Dis. 2003;6(4):301-4. doi: 10.1038/sj.pcan.4500679.

  PMID: 14663471 BACKGROUND

• Nangia-Makker P, Hogan V, Honjo Y, Baccarini S, Tait L, Bresalier R, Raz A. Inhibition of human cancer cell growth and metastasis in nude mice by oral intake of modified citrus pectin. J Natl Cancer Inst. 2002 Dec 18;94(24):1854-62. doi: 10.1093/jnci/94.24.1854.

  PMID: 12488479 BACKGROUND

• Tehranian N, Sepehri H, Mehdipour P, Biramijamal F, Hossein-Nezhad A, Sarrafnejad A, Hajizadeh E. Combination effect of PectaSol and Doxorubicin on viability, cell cycle arrest and apoptosis in DU-145 and LNCaP prostate cancer cell lines. Cell Biol Int. 2012 Jul;36(7):601-10. doi: 10.1042/CBI20110309.

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• Hayashi A, Gillen AC, Lott JR. Effects of daily oral administration of quercetin chalcone and modified citrus pectin on implanted colon-25 tumor growth in Balb-c mice. Altern Med Rev. 2000 Dec;5(6):546-52.

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• Pienta KJ, Naik H, Akhtar A, Yamazaki K, Replogle TS, Lehr J, Donat TL, Tait L, Hogan V, Raz A. Inhibition of spontaneous metastasis in a rat prostate cancer model by oral administration of modified citrus pectin. J Natl Cancer Inst. 1995 Mar 1;87(5):348-53. doi: 10.1093/jnci/87.5.348.

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• Platt D, Raz A. Modulation of the lung colonization of B16-F1 melanoma cells by citrus pectin. J Natl Cancer Inst. 1992 Mar 18;84(6):438-42. doi: 10.1093/jnci/84.6.438.

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• Gunning AP, Bongaerts RJ, Morris VJ. Recognition of galactan components of pectin by galectin-3. FASEB J. 2009 Feb;23(2):415-24. doi: 10.1096/fj.08-106617. Epub 2008 Oct 2.

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• Azemar M, Hildenbrand B, Haering B, Heim ME, Unger C. Clinical benefit in patients with advanced solid tumors treated with modified citrus pectin: a prospective pilot study. Clin Med: Oncol. 2007;1:73-80.

  BACKGROUND

• Calvier L, Miana M, Reboul P, Cachofeiro V, Martinez-Martinez E, de Boer RA, Poirier F, Lacolley P, Zannad F, Rossignol P, Lopez-Andres N. Galectin-3 mediates aldosterone-induced vascular fibrosis. Arterioscler Thromb Vasc Biol. 2013 Jan;33(1):67-75. doi: 10.1161/ATVBAHA.112.300569. Epub 2012 Nov 1.

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• Calvier L, Martinez-Martinez E, Miana M, Cachofeiro V, Rousseau E, Sadaba JR, Zannad F, Rossignol P, Lopez-Andres N. The impact of galectin-3 inhibition on aldosterone-induced cardiac and renal injuries. JACC Heart Fail. 2015 Jan;3(1):59-67. doi: 10.1016/j.jchf.2014.08.002. Epub 2014 Nov 11.

  PMID: 25458174 BACKGROUND

• Dange MC, Srinivasan N, More SK, Bane SM, Upadhya A, Ingle AD, Gude RP, Mukhopadhyaya R, Kalraiya RD. Galectin-3 expressed on different lung compartments promotes organ specific metastasis by facilitating arrest, extravasation and organ colonization via high affinity ligands on melanoma cells. Clin Exp Metastasis. 2014 Aug;31(6):661-73. doi: 10.1007/s10585-014-9657-2. Epub 2014 Jun 21.

  PMID: 24952269 BACKGROUND

• Hossein G, Keshavarz M, Ahmadi S, Naderi N. Synergistic effects of PectaSol-C modified citrus pectin an inhibitor of Galectin-3 and paclitaxel on apoptosis of human SKOV-3 ovarian cancer cells. Asian Pac J Cancer Prev. 2013;14(12):7561-8. doi: 10.7314/apjcp.2013.14.12.7561.

  PMID: 24460334 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

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

• Daniel Keizman, MD

  Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center

  PRINCIPAL INVESTIGATOR

• Isaac Eliaz, MD, LAc, MS

  Amitabha Medical Clinic and Healing Center

  STUDY DIRECTOR

• Moshe Frenkel, MD

  Clinical Associate Professor, University of Texas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP) Oral administration of PectaSol-C MCP (4.8 grams in six capsules three times a day away from food).

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 10, 2012
• Study Start: June 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

IL (1)