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

University of California (UC) Davis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: GCP - Genistein Combined Polysaccharide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00584532

281609

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

A=Placebo ARM of Study

Treatment:

Drug: Placebo

B

Active Comparator group

Description:

B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.

Treatment:

Drug: GCP - Genistein Combined Polysaccharide