Novel Window of Opportunity Trial to Evaluate the Impact of Statins to Oppose Prostate Cancer
NCT ID: NCT01992042
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2014-02-28
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fluvastatin/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.
Fluvastatin
HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily
Pimonidazole
Interventions
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Fluvastatin
HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily
Pimonidazole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. History of receiving radiation to the pelvic area
3. Past or current use of 5-alpha reductase inhibitors finasteride and/or dutasteride
4. History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
5. Statin use within 2 years of prostate cancer diagnosis
6. Known hypersensitivity towards any component of the investigational medicinal product.
7. 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
8. 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
9. 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
10. 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.
11. Use of any drug listed in Prohibited Medications List
12. Mental incapacity or language barrier precluding adequate understanding or co operation
13. 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
14. Patients who are unable or unwilling to undergo MRI testing
18 Years
75 Years
MALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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University Health Network- The Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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WIN-STOPCa_001
Identifier Type: -
Identifier Source: org_study_id