Prostate CancerPhase 2/3GCPNCT00584532
Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
A Phase 2/3 study testing GCP - Genistein Combined Polysaccharide in people with Prostate Cancer, run by University of California, Davis.
Trial summary
Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- GCP - Genistein Combined Polysaccharide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Dec 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
About this study
Official title: Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of 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.
- Conditions
- Prostate Cancer
- Being tested
- Placebo, GCP - Genistein Combined Polysaccharide
- Keywords
- Localized, Prostate, Cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo capsules (contain cellulose only)
10 Placebo Capsules taken orally every day.
GCP - Genistein Combined PolysaccharideDrug
Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | A=Placebo ARM of Study Receives: Drug: Placebo |
| B | Active comparator | B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day. Receives: Drug: GCP - Genistein Combined Polysaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in PSA levels in men on GCP
Measured: 6 Months
Secondary outcomes (1)
Increased PSA Doubling Time (PSADT)in men on GCP.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startNov 2003
- Primary completionDec 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Robert Hackman, MD, Principal investigator, University of California, Davis - Dept. of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584532
- Sponsor's protocol ID
- 281609
- Acronym
- GCP
- Status last verified
- Dec 2007
- First submitted
- 22 Dec 2007
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
- ClinicalTrials.gov ID
- NCT00584532
- Acronym / sponsor ID
- GCP / 281609
- Conditions
- Prostate Cancer
- Keywords
- Localized, Prostate, Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PlaceboA=Placebo ARM of Study |
| B | Active comparator | Drug: GCP - Genistein Combined PolysaccharideB=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Placebo capsules (contain cellulose only)10 Placebo Capsules taken orally every day. | Drug | A |
| GCP - Genistein Combined PolysaccharideTen 500 mg capsules given orally per day. Total of 5 grams per day per patient. | Drug | B |
Primary outcome
Decrease in PSA levels in men on GCP
Time frame: 6 Months
1 secondary outcome
Increased PSA Doubling Time (PSADT)in men on GCP.
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hackman, MD principal investigator
University of California, Davis - Dept. of Nutrition
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GCP - Genistein Combined Polysaccharide in people with Prostate Cancer, run by University of California, Davis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in PSA levels in men on GCP (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.