Novel Window of Opportunity Trial to Evaluate the Impact of Statins to Oppose Prostate Cancer
- Registration Number
- NCT01992042
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
This research study provides a novel opportunity to examine the intra-prostatic tumour inhibitory effects of statins in men with prostate cancer undergoing surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fluvastatin/Pimonidazole Fluvastatin 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. Fluvastatin/Pimonidazole 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.
- Primary Outcome Measures
Name Time Method Pre and post treatment effect on the Ki-67 proliferation index Week 8
- Secondary Outcome Measures
Name Time Method Comparison of immunohistochemical staining in Biopsy and post-RP tissues 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)
Trial Locations
- Locations (1)
University Health Network- The Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada