Clinical trial · Interventional
Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
NCT00584532CI-TRIAL-00071675GCPcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GCP - Genistein Combined Polysaccharide | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- A
- description
- A=Placebo ARM of Study
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
- interventionNames
- Drug: GCP - Genistein Combined Polysaccharide
Primary outcomes (1)
- measure
- Decrease in PSA levels in men on GCP
- timeFrame
- 6 Months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.