NCT02037464

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

2.4 years

First QC Date

January 14, 2014

Last Update Submit

January 14, 2014

Conditions

Prostate Cancer

Keywords

Prostate CancerActive SurveillanceRadical Prostatectomy

Outcome Measures

Primary Outcomes (1)

  • Biomarker Changes

    Determine effect of capsaicin therapy on expression of ki67 and p27 biomarkers in a post-treatment biopsy.

    6-8 weeks or 9 +/-3 months

Secondary Outcomes (3)

  • PSA Kinetics

    1 year

  • Tumor grade

    1 year

  • Biomarkers

    1 year

Study Arms (1)

Capsaicin Supplement

EXPERIMENTAL
Dietary Supplement: Capsaicin Supplement (Cayenne by Nature's Way)

Interventions

Capsaicin Supplement (Cayenne by Nature's Way)DIETARY_SUPPLEMENT

One capsule of the supplement to be taken twice daily.

Also known as: Naturesway Cayenne 40,000 H.U. (NPN #80013036)
Capsaicin Supplement

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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.)
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Laurence Klotz, MD

    Sunnybrook Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlene Kebabdjian

CONTACT

416-480-6100Marlene.Kebabdjian@sunnybrook.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Laurence Klotz

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

January 1, 2018

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

CA(1)