Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Lipid Regulating Agents

All Drugs and Chemicals

Hydroxymethylglutaryl-CoA Reductase Inhibitors

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

Fluvastatin

Pimonidazole

This research study provides a novel opportunity to examine the intra-prostatic tumour inhibitory effects of statins in men with prostate cancer undergoing surgery.

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

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)

University Health Network, Toronto

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Recurrence

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Disease Attributes

Neuroendocrine Tumor

Neuroepithelioma

Participants will receive Fluvastatin for 2 weeks.

RNA-sequencing and gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision.

RNA-sequencing will be completed on the original diagnostic biopsy and the final melanoma excision

RNA-sequencing

Gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision

Gene expression profiling

Wesley Yu, MD

The purpose of this study is to determine whether a medication, fluvastatin, can change melanoma to a state that is less likely to metastasize or recur.

Fluvastatin is experimental in this setting because it is not approved by the Food and Drug Administration (FDA) for treatment or prevention of melanoma. However, fluvastatin has been approved by the FDA for treating high cholesterol.

This is an open-label, single arm, study assessing the activity of fluvastatin in shifting the transcriptome in melanoma. Subjects with melanoma will be asked to participate and all subjects will receive the study drug, fluvastatin, for 2 weeks.

The primary objective of this study to determine whether administration of fluvastatin changes the melanoma transcriptome

The secondary objective of this study is to determine whether administration of fluvastatin changes the gene expression profile of Class 2 melanoma to Class 1 melanoma.

Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas

This study is a pilot study to help assess the power needed for a larger study and to determine biologic activity. If a larger study is conducted, data will be shared.

The study team will report which of the 28 genes had significant expression changes. A 2-fold change in the appropriate direction with a p-value of at least 0.05 will be considered significant for potential therapeutic value. P-values will be corrected for the false discovery rate using the Benjamini-Hochberg procedure. Fluvastatin successful in shifting the genetic profile in a therapeutic manner if at least half of the 28 genes have significant expression changes

Number of patients who convert from Class 2 to Class 1 profile on retesting

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Novel Window of Opportunity Trial to Evaluate the Impact of Statins to Oppose Prostate Cancer	NCT01992042	Prostate Cancer	Fluvastatin Pimonidazole	18 Years - 75 Years	University Health Network, Toronto
Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas	NCT04285749	Malignant Melan...	Fluvastatin RNA-sequencing Gene expression...	18 Years - 99 Years	Case Comprehensive Cancer Center
Novel Window of Opportunity Trial to Evaluate the Impact of Statins to Oppose Prostate Cancer	NCT01992042	Prostate Cancer	Fluvastatin Pimonidazole	18 Years - 75 Years	University Health Network, Toronto

Spots Global Cancer Trial Database for fluvastatin

Every month we try and update this database with for fluvastatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fluvastatin

Every month we try and update this database with for fluvastatin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fluvastatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.