Prostate Cancer
Conditions
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.
Interventions
DRUGFluvastatin
HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily
DRUGPimonidazole
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre and post treatment effect on the Ki-67 proliferation index | Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Canada
Outcome results
None listed