Prostate CancerNCT00269555
Effects of GCP on Prostate Cancer.
A study testing Genistein Combined Polysaccharide (GCP) in people with Prostate Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake mushrooms. This concentrated mixture is currently being sold in Japan and the United States and is thought to possibly contain properties that may be useful in treating certain types of 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?
- Genistein Combined Polysaccharide (GCP)
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Sep 2006
- Phase
- Interventional
- 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.
- No treatment (surgery [RRP], radiation, or hormones) prior to study entry.
- The patient has decided, after consultation with his own doctor, to have no treatment intervention (surgery [RRP], radiation, or hormones) for the next six months.
- 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).
- -
Who cannot join
- No pathological documentation of prostate cancer.
- Allergy to soy or soy products
- Prior history of treatment for prostate cancer.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake mushrooms. This concentrated mixture is currently being sold in Japan and the United States and is thought to possibly contain properties that may be useful in treating certain types of cancer.
- Conditions
- Prostate Cancer
- Being tested
- Genistein Combined Polysaccharide (GCP)
- Keywords
- Prostate, Cancer, Prostate Specific Antigen, C04.588.945.440.770
- 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.
Genistein Combined Polysaccharide (GCP)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in PSA serum levels.
Secondary outcomes (1)
Stabilization of PSA serum levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startMay 2004
- Primary completionJan 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 62 participants
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Robert Hackman, PhD, Principal investigator, University of California, DavisRalph W deVere White, MD, Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269555
- Sponsor's protocol ID
- 200412146
- Status last verified
- Jun 2010
- First submitted
- 22 Dec 2005
- Last updated
- 29 Jun 2010
- Results posted
- No
Publications
deVere White RW, Hackman RM, Soares SE, Beckett LA, Li Y, Sun B. Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer. Urology. 2004 Feb;63(2):259-63. doi: 10.1016/j.urology.2003.09.061.
PubMed 14972467
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
- ClinicalTrials.gov ID
- NCT00269555
- Acronym / sponsor ID
- 200412146
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Prostate Specific Antigen, C04.588.945.440.770
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 23 Dec 2005 (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) is derived from adding soy powder to shiitake mushrooms. This concentrated mixture is currently being sold in Japan and the United States and is thought to possibly contain properties that may be useful in treating certain types of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be male and have a pathological diagnosis of prostate cancer.
- No treatment (surgery [RRP], radiation, or hormones) prior to study entry.
- The patient has decided, after consultation with his own doctor, to have no treatment intervention (surgery [RRP], radiation, or hormones) for the next six months.
- 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 (4 listed)
- No pathological documentation of prostate cancer.
- Allergy to soy or soy products
- Prior history of treatment for prostate cancer.
- -
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 |
|---|---|---|
| Genistein Combined Polysaccharide (GCP) | Drug | – |
Primary outcome
Reduction in PSA serum levels.
1 secondary outcome
Stabilization of PSA serum levels.
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 29 Jun 2010.
- Background: PubMed 14972467deVere White RW, Hackman RM, Soares SE, Beckett LA, Li Y, Sun B. Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer. Urology. 2004 Feb;63(2):259-63. doi: 10.1016/j.urology.2003.09.061.
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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, PhD principal investigator
University of California, Davis
Ralph W deVere White, MD study director
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genistein Combined Polysaccharide (GCP) in people with Prostate Cancer, run by University of California, Davis at 1 site in United States.
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 8 inclusion and 4 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 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Reduction in PSA serum levels.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00269555, which also lists 1 linked publication.
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 29 Jun 2010.