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

NCT01992042 | Completed Phase 2 DMC

• 1 other identifier: WIN-STOPCa_001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Pre and post treatment effect on the Ki-67 proliferation index

  Week 8

Secondary Outcomes (1)

• Comparison of immunohistochemical staining in Biopsy and post-RP tissues

  Week 8

Study Arms (1)

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.

Drug: Fluvastatin; Drug: Pimonidazole

Interventions

Fluvastatin DRUG

HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily

Also known as: Lescol

Fluvastatin/Pimonidazole

Pimonidazole DRUG

Fluvastatin/Pimonidazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network- The Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 32203069 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fluvastatin; pimonidazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: February 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

CA (1)