- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01992042
Novel Window of Opportunity Trial to Evaluate the Impact of Statins to Oppose Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5G2M9
- University Health Network- The Princess Margaret Cancer Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- Men >18 and < 75 years of age
- Willing and able to provide informed consent, either alone or with the aid of a translator
- Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
- Prostate cancer that is Gleason grade ≥ 7 involving at least 30% of one unfragmented biopsy core
- Candidates for radical prostatectomy considered surgically resectable, either open or robotic, by urologic evaluation
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
- 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:
- 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)
- History of receiving radiation to the pelvic area
- Past or current use of 5-alpha reductase inhibitors finasteride and/or dutasteride
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- Statin use within 2 years of prostate cancer diagnosis
- Known hypersensitivity towards any component of the investigational medicinal product.
- 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
- 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
- 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
- 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.
- Use of any drug listed in Prohibited Medications List
- Mental incapacity or language barrier precluding adequate understanding or co operation
- 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
- Patients who are unable or unwilling to undergo MRI testing
Study Plan
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:
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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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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