Prostate CancerPhase 2CAPSAICINNCT02037464
CAPSAICIN Trial: Assessing Capsaicin as a Chemopreventive Agent for Prostate Cancer
A Phase 2 study testing Capsaicin Supplement (Cayenne by Nature's Way) in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine the chemopreventive properties of capsaicin, the active compound in chili peppers, in prostate cancer patients enrolled in the active surveillance program or patients scheduled to undergo radical prostatectomy. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Capsaicin Supplement (Cayenne by Nature's Way)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jan 2018
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is >19 years of age
- Subject has a histologically documented diagnosis of prostate adenocarcinoma
- Being monitored by active surveillance (see Table 1) for favourable risk prostate cancer as defined by the following:
- Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis
- Clinical (diagnostic biopsy) Gleason score < 6
- PSA < 10.0 ng/ml (ug/L)
- Tumour material from most recent prostate biopsy available with sample (up to 10 unstained slides) collected for determination of ki67 and p27 biomarker expression.
- 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 (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (Ta bladder cancer with negative surveillance cystoscopy within the past 2 years may be included.)
- No previous or current treatment (medical therapy or radical intervention) for prostate cancer excluding biopsy
- Inability to undergo TRUS biopsy
- Concurrent administration of the following medications is not permitted during the protocol:
- 5 α-reductase inhibitors
- Cytotoxic chemotherapy
Show all 17Show fewer
- Immunotherapy
- Hormonal therapy (megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol, hyrodcortisone, etc.)
- Non-steroidal anti-androgens (bicalutamide, nilutamide, flutamide, etc.)
- Luteinizing hormone releasing Hormone (LHRH) analogues (leuprolide, goserelin, etc.)
- Ketoconazole
- PC-SPES and any other preparations thought to have endocrine effects
- Medications which inhibit cholesterogenesis ('statin' medications, etc.)
- Eastern Cooperative Oncology Group (ECOG) Performance Status > 2
- Known or history of liver disease (total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 upper limit of normal at screening visit)
- Subject has a minimum life expectancy of < 5 years
- Subject is unable to give written and informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
Marlene Kebabdjian, marlene.kebabdjian@sunnybrook.ca
Laurence Klotz, MD
About this study
Official title: CAPSAICIN Trial: A Prospective Study of Capsaicin in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance or Radical Prostatectomy
The purpose of this study is to determine the chemopreventive properties of capsaicin, the active compound in chili peppers, in prostate cancer patients enrolled in the active surveillance program or patients scheduled to undergo radical prostatectomy.
Read the detailed description
Rationale A large body of evidence supports the role of dietary factors in prostate cancer development and progression. Most of this evidence suggests that diet high in fat including red meat and low in micronutrients and other anti-oxidants, increases the risk of disease. We are interested in the therapeutic potential of the dietary agent, capsaicin (CAP). Capsaicin is the active compound in chili peppers, and related plants. Pre-clinical studies have found that capsaicin has potent growth inhibitory and pro-apoptotic effects. It is thought that consumption of a capsaicin supplement may have a clinical benefit for subjects with localized prostate cancer who have chosen to be managed by active surveillance or improve surgical outcome of patients undergoing radical prostatectomy.
Objective(s) Primary • To assess the effect of capsaicin daily therapy on the expression of ki67 and p27 biomarkers in a post-treatment biopsy or prostate specimen from RP.
Secondary
- To assess the effect of therapy with repeat oral dosing of capsaicin two times daily on Prostate Specific Antigen (PSA) kinetics in men on active surveillance for localized prostate cancer
- To assess the effect of therapy with repeat oral dosing of capsaicin two times daily on grade and the presence of prostatic intraepithelial neoplasia (PIN) in a post-treatment biopsy
- To assess the effect of therapy with repeat oral dosing of capsaicin two times daily on the expression of markers of apoptosis, cell cycle, TRP-V1 and TRP-V6
- To assess the safety and tolerability of capsaicin therapy in men on active surveillance (AS) for prostate cancer
- To assess alterations in prostate volume and time to recurrence
Endpoint(s) Primary
- Determine effect of capsaicin therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy
Secondary
- Determine effect of capsaicin daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer
- To evaluate the effect of capsaicin daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy
- To assess the effect of capsaicin therapy on the expression of markers of apoptosis, cell cycle, TRP-V1 and TRP-V6
Safety and Tolerability
- Adverse events (AEs)
- Clinical laboratory evaluations (PSA, electrolytes, biochemistry, hematology, cholesterol)
Pharmacodynamic
- Levels of serum capsaicin (CAP)
- Levels of serum testosterone (T)
Study Design This is a phase II, open label, single centre study to evaluate the efficacy and safety of repeat oral dosing of one CAP capsules twice times daily for 6 months prior to a prostate biopsy in men on active surveillance for localized prostate cancer, as well as 6 weeks prior to radical prostatectomy (RP).
Study Population One hundred men men monitored (sixty from active surveillance (AS) and forty patients scheduled to undergo radical prostatectomy) will be eligible for participation. Subjects must satisfy all inclusion and exclusion criteria. A sufficient number will be enrolled to achieve at least 100 completed subjects
- Conditions
- Prostate Cancer
- Being tested
- Capsaicin Supplement (Cayenne by Nature's Way)
- Keywords
- Prostate Cancer, Active Surveillance, Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin Supplement (Cayenne by Nature's Way)Dietary supplement
Also called Naturesway Cayenne 40,000 H.U. (NPN #80013036)
One capsule of the supplement to be taken twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin Supplement | Experimental | Not described Receives: Dietary Supplement: Capsaicin Supplement (Cayenne by Nature's Way) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker Changes
Determine effect of capsaicin therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy.
Measured: 6-8 weeks or 9 +/-3 months
Secondary outcomes (3)
PSA Kinetics
Measured: 1 year
Tumor grade
Measured: 1 year
Biomarkers
To assess the effect of capsaicin therapy on the expression of markers of apoptosis, cell cycle, TRP-V1 and TRP-V6
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016 (estimated)
- Study completionJan 2018 (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.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Laurence Klotz, Sunnybrook Health Sciences Centre
- Investigators
- Laurence Klotz, MD, Principal investigator, Sunnybrook Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037464
- Sponsor's protocol ID
- 264-2013
- Acronym
- CAPSAICIN
- Status last verified
- Jan 2014
- First submitted
- 14 Jan 2014
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPSAICIN Trial: A Prospective Study of Capsaicin in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance or Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02037464
- Acronym / sponsor ID
- CAPSAICIN / 264-2013
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Active Surveillance, Radical Prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 16 Jan 2014 (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.
The purpose of this study is to determine the chemopreventive properties of capsaicin, the active compound in chili peppers, in prostate cancer patients enrolled in the active surveillance program or patients scheduled to undergo radical prostatectomy.
Detailed description
Rationale A large body of evidence supports the role of dietary factors in prostate cancer development and progression. Most of this evidence suggests that diet high in fat including red meat and low in micronutrients and other anti-oxidants, increases the risk of disease. We are interested in the therapeutic potential of the dietary agent, capsaicin (CAP). Capsaicin is the active compound in chili peppers, and related plants. Pre-clinical studies have found that capsaicin has potent growth inhibitory and pro-apoptotic effects. It is thought that consumption of a capsaicin supplement may have a clinical benefit for subjects with localized prostate cancer who have chosen to be managed by active surveillance or improve surgical outcome of patients undergoing radical prostatectomy.
Objective(s) Primary • To assess the effect of capsaicin daily therapy on the expression of ki67 and p27 biomarkers in a post-treatment biopsy or prostate specimen from RP.
Secondary
- To assess the effect of therapy with repeat oral dosing of capsaicin two times daily on Prostate Specific Antigen (PSA) kinetics in men on active surveillance for localized prostate cancer
- To assess the effect of therapy with repeat oral dosing of capsaicin two times daily on grade and the presence of prostatic intraepithelial neoplasia (PIN) in a post-treatment biopsy
- To assess the effect of therapy with repeat oral dosing of capsaicin two times daily on the expression of markers of apoptosis, cell cycle, TRP-V1 and TRP-V6
- To assess the safety and tolerability of capsaicin therapy in men on active surveillance (AS) for prostate cancer
- To assess alterations in prostate volume and time to recurrence
Endpoint(s) Primary
- Determine effect of capsaicin therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy
Secondary
- Determine effect of capsaicin daily therapy on PSA kinetics in men on active surveillance for localized prostate cancer
- To evaluate the effect of capsaicin daily therapy on grade and the presence of prostatic intraepithelial neoplasia (PIN) in post treatment biopsy
- To assess the effect of capsaicin therapy on the expression of markers of apoptosis, cell cycle, TRP-V1 and TRP-V6
Safety and Tolerability
- Adverse events (AEs)
- Clinical laboratory evaluations (PSA, electrolytes, biochemistry, hematology, cholesterol)
Pharmacodynamic
- Levels of serum capsaicin (CAP)
- Levels of serum testosterone (T)
Study Design This is a phase II, open label, single centre study to evaluate the efficacy and safety of repeat oral dosing of one CAP capsules twice times daily for 6 months prior to a prostate biopsy in men on active surveillance for localized prostate cancer, as well as 6 weeks prior to radical prostatectomy (RP).
Study Population One hundred men men monitored (sixty from active surveillance (AS) and forty patients scheduled to undergo radical prostatectomy) will be eligible for participation. Subjects must satisfy all inclusion and exclusion criteria. A sufficient number will be enrolled to achieve at least 100 completed subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capsaicin Supplement | Experimental | Dietary Supplement: Capsaicin Supplement (Cayenne by Nature's Way) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is >19 years of age
- Subject has a histologically documented diagnosis of prostate adenocarcinoma
- Being monitored by active surveillance (see Table 1) for favourable risk prostate cancer as defined by the following:
- Tumour material from most recent prostate biopsy available with sample (up to 10 unstained slides) collected for determination of ki67 and p27 biomarker expression.
- 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 (17 listed)
- Previous malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (Ta bladder cancer with negative surveillance cystoscopy within the past 2 years may be included.)
- No previous or current treatment (medical therapy or radical intervention) for prostate cancer excluding biopsy
- Inability to undergo TRUS biopsy
- Concurrent administration of the following medications is not permitted during the protocol:
- Eastern Cooperative Oncology Group (ECOG) Performance Status > 2
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 |
|---|---|---|
| Capsaicin Supplement (Cayenne by Nature's Way)Also: Naturesway Cayenne 40,000 H.U. (NPN #80013036)One capsule of the supplement to be taken twice daily. | Dietary supplement | Capsaicin Supplement |
Primary outcome
Biomarker Changes
Time frame: 6-8 weeks or 9 +/-3 months
Determine effect of capsaicin therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy.
3 secondary outcomes
PSA Kinetics
Time frame: 1 year
Tumor grade
Time frame: 1 year
Biomarkers
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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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 Hospital
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 Capsaicin Supplement (Cayenne by Nature's Way) in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre 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 8 inclusion and 17 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 16 Jan 2014. 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 (416-480-6100, Marlene.Kebabdjian@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker Changes (time frame: 6-8 weeks or 9 +/-3 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 16 Jan 2014.