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

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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

Condition: Prostatic Neoplasms

Intervention:

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

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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01681823

Sponsor: EcoNugenics

Primary Outcome Measures:

  • Measure: Prostate Specific Antigen (PSA) kinetics in men with biochemical relapsed prostate cancer and serial increases in PSA levels.
  • Time Frame: 6 month endpoint.
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: An assessment of adverse side effects due to Modified Citrus Pectin (MCP).
  • Time Frame: 6 month endpoint.
  • Safety Issue:

Estimated Enrollment: 60

Study Start Date: June 2013

Phase: Phase 2

Eligibility:

  • Age: minimum 21 Years maximum N/A
  • Gender: Male

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.

Contact:

  • Daniel Keizman, M.D.
  • +972 (0)9 747 2714

Location:

  • Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59,
  • Kfar-Saba Israel

View trial on ClinicalTrials.gov

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