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The Effect of PectaSol-C MCP on PSA Kinetics in Biochemical Relapsed PC Patients With Serial Increases in PSA

This study is not yet open for participant recruitment.
Verified December 2012 by EcoNugenics
Sponsor:
Information provided by (Responsible Party):
EcoNugenics
ClinicalTrials.gov Identifier:
NCT01681823
First received: September 6, 2012
Last updated: May 22, 2013
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
 Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III, Randomized, Crossover, Double-Blind, Placebo-Controlled 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

Resource links provided by NLM:

Drug Information available for: Pectin
U.S. FDA Resources

Further study details as provided by EcoNugenics:

Primary Outcome Measures:
  • Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    PSA doubling time increase will be used to show effectiveness of the Modified Citrus pectin (MCP).


Secondary Outcome Measures:
  • An assessment of adverse side effects due to Modified Citrus Pectin (MCP). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Patient tolerability of MCP will be assessed by comparing the results of weekly self-assessment diaries with baseline assessments.


Other Outcome Measures:
  • Blood Serum Analysis (Galectin-3, C-Reactive Protein, Lipid Panels) [ Time Frame: Baseline, 6 month crossover point, 12 month endpoint. ] [ Designated as safety issue: No ]
    At baseline (0 month), crossover midpoint (6 month), and end of study (12 month): Blood draw for serum levels of galectin-3, C-reactive protein, and lipid panel.


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PectaSol-C Modified Citrus Pectin
First six months of treatment with PectaSol-C Modified Citrus Pectin (4.8 grams in 6 capsules) three times a day away from meals, then a switch to opposite treatment of Matched Blinded Placebo (6 capsules) three times a day away from meals, for the remaining six months.
 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).
Placebo Comparator: Matched Blinded Placebo
First six months of treatment with Matched Blinded Placebo (6 capsules) three times a day away from meals, then a switch to opposite treatment PectaSol-C Modified Citrus Pectin (4.8 grams in 6 capsules) three times a day away from meals, for the remaining six months.
 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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681823

Contacts
Contact: Daniel Keizman, M.D. +972 (0)9 747 2714 danielkeizman@gmail.com
Contact: Moshe Frenkel, M.D. +972 (0)52 331 1255 office@moshefrenkelmd.com

Locations
Israel
Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59,
Kfar-Saba, Israel
Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center
Kfar-Saba, Israel
Sponsors and Collaborators
EcoNugenics
Investigators
Principal Investigator: Daniel Keizman, MD Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center
Study Director: Isaac Eliaz, MD, LAc, MS Amitabha Medical Clinic and Healing Center
Study Chair: Moshe Frenkel, MD Clinical Associate Professor, University of Texas
  More Information

Publications:

Responsible Party: EcoNugenics
ClinicalTrials.gov Identifier: NCT01681823     History of Changes
Other Study ID Numbers: MMC12192-12CTIL
Study First Received: September 6, 2012
Last Updated: May 22, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by EcoNugenics:
Prostate Cancer
Prostatic Neoplasms
Prostate Specific Antigen
 Modified Citrus Pectin
PectaSol-C
Biochemical Relapse

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
 Prostatic Diseases
Pectin
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013