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

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584532
First received: December 22, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Placebo
Drug: GCP - Genistein Combined Polysaccharide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Decrease in PSA levels in men on GCP [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased PSA Doubling Time (PSADT)in men on GCP. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: November 2003
Study Completion Date: December 2007
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
A=Placebo ARM of Study
Drug: Placebo
10 Placebo Capsules taken orally every day.
Other Name: Placebo capsules (contain cellulose only)
Active Comparator: B
B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
Drug: GCP - Genistein Combined Polysaccharide
Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584532

Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Robert Hackman, MD University of California, Davis - Dept. of Nutrition
  More Information

No publications provided

Responsible Party: Robert Hackman, PhD, University of California, Davis - Department of Nutrition
ClinicalTrials.gov Identifier: NCT00584532     History of Changes
Other Study ID Numbers: 200412146-5
Study First Received: December 22, 2007
Last Updated: December 22, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Localized
Prostate
Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Genistein
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014