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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992042
• Other study ID #: WIN-STOPCa_001
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2013
• Last updated: October 24, 2017
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Fluvastatin
HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily
• Pimonidazole

Locations

Country	Name	City	State
Canada	University Health Network- The Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre and post treatment effect on the Ki-67 proliferation index		Week 8
Secondary	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)	Week 8