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This research study provides a novel opportunity to examine the intra-prostatic tumour inhibitory effects of statins in men with prostate cancer undergoing surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluvastatin/Pimonidazole | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvastatin | Drug | HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre and post treatment effect on the Ki-67 proliferation index | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of immunohistochemical staining in Biopsy and post-RP tissues | 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) |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network- The Princess Margaret Cancer Centre | Toronto | Ontario | M5G2M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32203069 | Derived | Longo J, Hamilton RJ, Masoomian M, Khurram N, Branchard E, Mullen PJ, Elbaz M, Hersey K, Chadwick D, Ghai S, Andrews DW, Chen EX, van der Kwast TH, Fleshner NE, Penn LZ. A pilot window-of-opportunity study of preoperative fluvastatin in localized prostate cancer. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):630-637. doi: 10.1038/s41391-020-0221-7. Epub 2020 Mar 13. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077340 | Fluvastatin |
| C033815 | pimonidazole |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Pimonidazole | Drug |
|
| Week 8 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |