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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992042
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Fluvastatin Drug: Pimonidazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Window of Opportunity Trial to Evaluate the Impact of Statins to Oppose Prostate Cancer
Actual Study Start Date : February 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Fluvastatin
HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily
Other Name: Lescol

Drug: Pimonidazole



Primary Outcome Measures :
  1. Pre and post treatment effect on the Ki-67 proliferation index [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Comparison of immunohistochemical staining in Biopsy and post-RP tissues [ Time Frame: 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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 exclusion criteria may not be entered into the study:

  1. 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)
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992042


Locations
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Canada, Ontario
University Health Network- The Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9
Sponsors and Collaborators
University Health Network, Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01992042    
Other Study ID Numbers: WIN-STOPCa_001
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases