Clinical trial · Interventional
Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA
Phase III, Single-Center, Open Label, Trial Evaluating the Safety and Efficacy of PectaSol-C Modified Citrus Pectin on PSA Kinetics in Prostate Cancer in the Setting of Serial Increases in PSA
NCT01681823CI-TRIAL-00043067completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PectaSol-C Modified Citrus Pectin (MCP) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PectaSol-C Modified Citrus Pectin (MCP)
- description
- Treatment with 4.8 grams PectaSol-C Modified Citrus Pectin three times a day, away from meals for six months.
- interventionNames
- Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)
Primary outcomes (1)
- measure
- Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels.
- timeFrame
- 6 month endpoint.
- description
- PSA doubling time increase will be used to show effectiveness of the Modified Citrus pectin (MCP).
Secondary outcomes (1)
- measure
- An assessment of adverse side effects due to Modified Citrus Pectin (MCP).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (25)
- BACKGROUNDKeizman 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
- BACKGROUNDAntonarakis 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. PMID 21960118
- BACKGROUNDNangia-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. PMID 11927277
- BACKGROUNDYan 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
- BACKGROUNDKolatsi-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
- BACKGROUNDRamachandran 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
- BACKGROUNDJiang 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.