Prostate CancerPhase 2NCT01687049
Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
A Phase 2 study testing Red yeast rice in people with Prostate Cancer, run by Dr. Laurence Klotz at 1 site in Canada.
Trial summary
Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing statins which are known to inhibit cholesterol synthesis. Read more about this study
- Who is it for?
- Ages 19 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Red yeast rice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Dec 2017
- Phase
- Phase 2
- 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 19 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically diagnosis of prostate adenocarcinoma
- being monitored by active surveillance for favourable risk prostate cancer
- tumour material from most recent prostate biopsy available with sample
- scheduled to have an active surveillance mandated transrectal ultrasound (TRUS) guided biopsy within 6 - 12 months of Day 1 of the study
Who cannot join
- previous malignancy in the past 5 years
- no previous or concurrent treatment for prostate cancer
- inability to undergo TRUS biopsy
- ECOG > 2
- known or previous history of liver disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Laurence Klotz, Md
About this study
Official title: A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown that RYR has direct effects on androgen dependent and androgen independent prostate cancer cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those subjects with localized prostate cancer who have chosen to be managed by active surveillance.
Read the detailed description
Red yeast rice has been promoted as a safe and effective alternative to statin therapy in the treatment of hypercholesterolemia. Red yeast rice has the potential to slow prostate cancer growth by inhibiting cholesterol and androgen biosynthesis. There is a strong rationale for the use of RYR in patients being managed with active surveillance for localized, low risk, prostate cancer. To date, no human studies utilizing RYR in this setting have been reported.
- Conditions
- Prostate Cancer
- Being tested
- Red yeast rice
- Keywords
- nonmetastatic, localized, prostate, active surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red yeast riceDrug
Also called Aliperol
| Study group | Role | What they receive |
|---|---|---|
| red yeast rice (RYR) | Experimental | Two RYR capsules three times daily for a minimum of 6 months Receives: Drug: Red yeast rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of Ki-67 and p27 biomarkers
Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy
Measured: 6 months
Secondary outcomes (3)
PSA kinetics
Determine effect of red yeast rice daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer
Measured: 6 months
Presence of prostatic interepithelial neoplasia
To evaluate the effect of red yeast rice daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy
Measured: 6 months
Expression of hs-CRP and cardiac CRP
To assess the effect of red yeast rice therapy on the expression of high sensitivity C-reactive protein (hs-CRP) and cardiac C-reactive protein (CRP) in serum
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 posted18 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Laurence Klotz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Laurence Klotz, Sunnybrook Health Sciences Centre
- Investigators
- Laurence Klotz, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687049
- Sponsor's protocol ID
- REALITY
- Other IDs
- SHSC
- Status last verified
- Nov 2012
- First submitted
- 13 Sep 2012
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Red Yeast Rice in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
- ClinicalTrials.gov ID
- NCT01687049
- Acronym / sponsor ID
- REALITY
- Conditions
- Prostate Cancer
- Keywords
- nonmetastatic, localized, prostate, active surveillance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Laurence KlotzUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Sep 2012 (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.
Agents that inhibit cholesterol synthesis are being investigated in cancers dependent upon cholesterogenesis. Red yeast rice (RYR), is a reddish-purple fermented rice, containing statins which are known to inhibit cholesterol synthesis. Laboratory studies have also shown that RYR has direct effects on androgen dependent and androgen independent prostate cancer cells, inhibiting their growth. It is thought that RYR may have clinical benefit in those subjects with localized prostate cancer who have chosen to be managed by active surveillance.
Detailed description
Red yeast rice has been promoted as a safe and effective alternative to statin therapy in the treatment of hypercholesterolemia. Red yeast rice has the potential to slow prostate cancer growth by inhibiting cholesterol and androgen biosynthesis. There is a strong rationale for the use of RYR in patients being managed with active surveillance for localized, low risk, prostate cancer. To date, no human studies utilizing RYR in this setting have been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| red yeast rice (RYR) | Experimental | Drug: Red yeast riceTwo RYR capsules three times daily for a minimum of 6 months |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically diagnosis of prostate adenocarcinoma
- being monitored by active surveillance for favourable risk prostate cancer
- tumour material from most recent prostate biopsy available with sample
- scheduled to have an active surveillance mandated transrectal ultrasound (TRUS) guided biopsy within 6 - 12 months of Day 1 of the study
Key exclusion criteria (5 listed)
- previous malignancy in the past 5 years
- no previous or concurrent treatment for prostate cancer
- inability to undergo TRUS biopsy
- ECOG > 2
- known or previous history of liver disease
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 |
|---|---|---|
| Red yeast riceAlso: Aliperol | Drug | red yeast rice (RYR) |
Primary outcome
Expression of Ki-67 and p27 biomarkers
Time frame: 6 months
Determine effect of red yeast rice therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy
3 secondary outcomes
PSA kinetics
Time frame: 6 months
Presence of prostatic interepithelial neoplasia
Time frame: 6 months
Expression of hs-CRP and cardiac CRP
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
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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.
Laurence Klotz, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Red yeast rice in people with Prostate Cancer, run by Dr. Laurence Klotz at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2012. 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 Canada. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlene Kebabdjian, BA (416-480-6100 ext. 7939, marlene.kebabdjian@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of Ki-67 and p27 biomarkers (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 7 Nov 2012.