Novel Window of Opportunity Trial to Evaluate the Impact of Statins to Oppose Prostate Cancer

October 24, 2017 updated by: University Health Network, Toronto
This research study provides a novel opportunity to examine the intra-prostatic tumour inhibitory effects of statins in men with prostate cancer undergoing surgery.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G2M9
        • University Health Network- The Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

The study population will consist of patients with localized prostate cancer that have elected radical prostatectomy as a primary treatment. Eligible patients will have prostate cancer that is Gleason Score ≥ 7.

Patients who meet all of the following inclusion criteria will be eligible to participate in this study:

  1. Men >18 and < 75 years of age
  2. Willing and able to provide informed consent, either alone or with the aid of a translator
  3. Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
  4. Prostate cancer that is Gleason grade ≥ 7 involving at least 30% of one unfragmented biopsy core
  5. Candidates for radical prostatectomy considered surgically resectable, either open or robotic, by urologic evaluation
  6. Normal organ and marrow function as defined by the following criteria:

    i. absolute neutrophil count >1,500/uL

    ii. platelets >100,000/uL

    iii. total bilirubin <1.5 X institutional ULN

    iv. AST (SGOT) or ALT (SGPT) <1.5 X institutional ULN

    v. creatinine <1.5 X institutional ULN

  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria

Any patient meeting one or more of the following exclusion criteria may not be entered into the study:

  1. Previous or current use of neo-adjuvant or hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate and ketoconazole)
  2. History of receiving radiation to the pelvic area
  3. Past or current use of 5-alpha reductase inhibitors finasteride and/or dutasteride
  4. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
  5. Statin use within 2 years of prostate cancer diagnosis
  6. Known hypersensitivity towards any component of the investigational medicinal product.
  7. Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years
  8. Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial
  9. Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator
  10. Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to enrollment.
  11. Use of any drug listed in Prohibited Medications List
  12. Mental incapacity or language barrier precluding adequate understanding or co operation
  13. Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial
  14. Patients who are unable or unwilling to undergo MRI testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fluvastatin/Pimonidazole
Patients will take 40mg BID of fluvastatin. The day before surgery patients will take a single dose of pimonidazole that will be calculate based on body surface area.
HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily
Other Names:
  • Lescol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pre and post treatment effect on the Ki-67 proliferation index
Time Frame: Week 8
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of immunohistochemical staining in Biopsy and post-RP tissues
Time Frame: Week 8

Will measure:

i. Apoptosis (caspase 3) ii. Signaling (Rap1A, Rap, RhoB) iii. Mevalonate pathway proteins (HMG-CoA reductase, HMG-CoA synthase, SREBP1/2, mevalonate decarboxylase, GGPS1, GGT, FT) iv. Tumour Infiltrating Lymphocytes (TILs), CD3 (T-cells), CD20 (B-cells), CD68 (macrophages), CD56 (NK cells), IDO (negative control)) v. Growth and survival signaling (AKT, P-AKT, ERK, P-ERK)

Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • WIN-STOPCa_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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