Clinical trial · Interventional
CAPSAICIN Trial: Assessing Capsaicin as a Chemopreventive Agent for Prostate Cancer
CAPSAICIN Trial: A Prospective Study of Capsaicin in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance or Radical Prostatectomy
NCT02037464CI-TRIAL-00013482CAPSAICINunknownPhase 2ClinicalTrials.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)
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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capsaicin Supplement (Cayenne by Nature's Way) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capsaicin Supplement
- interventionNames
- Dietary Supplement: Capsaicin Supplement (Cayenne by Nature's Way)
Primary outcomes (1)
- measure
- Biomarker Changes
- timeFrame
- 6-8 weeks or 9 +/-3 months
- description
- Determine effect of capsaicin therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy.
Secondary outcomes (3)
- measure
- PSA Kinetics
- timeFrame
- 1 year
- measure
- Tumor grade
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria:
1. Subject is \>19 years of age
2. Subject has a histologically documented diagnosis of prostate adenocarcinoma
3. Being monitored by active surveillance (see Table 1) for favourable risk prostate cancer as defined by the following:
1. Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis
2. Clinical (diagnostic biopsy) Gleason score \< 6
3. PSA \< 10.0 ng/ml (ug/L)
4. Tumour material from most recent prostate biopsy available with sample (up to 10 unstained slides) collected for determination of ki67 and p27 biomarker expression.
5. Scheduled to have an active surveillance mandated transrectal ultrasound (TRUS) guided biopsy within 6 - 12 months of Day 1 of the study
Exclusion Criteria:
1. 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.)
2. No previous or current treatment (medical therapy or radical intervention) for prostate cancer excluding biopsy
3. Inability to undergo TRUS biopsy
4. Concurrent administration of the following medications is not permitted during the protocol:
* 5 α-reductase inhibitors
* Cytotoxic chemotherapy
* 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.)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status \> 2
6. Known or history of liver disease (total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 upper limit of normal at screening visit)
7. Subject has a minimum life expectancy of \< 5 years
8. Subject is unable to give written and informed consentReferences
Publications (0)
Data not yet available
No reference posted for this study.