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OpenTrials
Completed

NCT Number: NCT00584532

Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.

Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be male and have a pathological diagnosis of prostate cancer
  • Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.
  • No treatment (surgery, radiation, or hormones) prior to study entry.
  • PSA between 2.0 and 10.0 ng/ml.
  • If PSA is >10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.
  • No known allergy to soy or soy products.
  • The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).
  • Participant has not been on any previous GCP clinical trial.
  • Normal Chemistry values prior to study entry.

Exclusion criteria

  • No pathological documentation of prostate cancer.
  • Prior treatment for prostate cancer.
  • PSA >10.0 ng/ml but not on Active Surveillance for 12 months.
  • Allergy to soy or soy products.
  • Abnormal chemistry values.

Treatment and study plan

Placebo

Drug

10 Placebo Capsules taken orally every day.

Other names: Placebo capsules (contain cellulose only)

GCP - Genistein Combined Polysaccharide

Drug

Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.

Primary outcomes

  1. Decrease in PSA levels in men on GCP

    Time frame: 6 Months

Secondary outcomes

  1. Increased PSA Doubling Time (PSADT)in men on GCP.

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.

Acronym: GCP

Important dates

Study start
2003
Primary completion
2005
Study completion
2007
First posted
Jan 2, 2008
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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