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Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
finasteride 5mg oral daily
Sponsored by
CancerCare Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • male
  • age >18
  • biopsy-proven non-small cell lung cancer
  • surgical intervention planned

Exclusion Criteria:

  • current use of 5-alpha reductase inhibitor
  • previous diagnosis of prostate cancer
  • previous hypersensitivity to 5-alpha reductase inhibitor

Sites / Locations

  • Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

finasteride

Arm Description

finasteride 5mg po od from study entry to date of surgery

Outcomes

Primary Outcome Measures

Change in proliferation
Patients will be followed from time of consent (around the time of consultation with a Thoracic Surgeon) to date of surgery (on average, approximately 4-6 weeks following Thoracic Surgeon consultation).

Secondary Outcome Measures

Full Information

First Posted
February 2, 2014
Last Updated
August 28, 2018
Sponsor
CancerCare Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02055170
Brief Title
Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
Official Title
Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to improve on poor accrual to study.
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 27, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CancerCare Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to study the effect of hormone therapies (androgen pathway modification) on the outcomes of patients with lung cancer. This information may be of benefit for future treatment strategies, prevention and control. In this study, the protein where testosterone binds, called the androgen receptor (AR), will be measured in samples from the patient's biopsy and surgical tumor samples. The investigators will look at a marker of how fast the cancer is growing (Ki67) before using finasteride from your biopsy specimen. Finasteride will be taken from the day of consent until the day of the patient's surgery. This marker will be measured again after using finasteride from the surgical specimen. The investigators will be looking for a decrease in the Ki67 from the patient's biopsy specimen to the surgical specimen as an indicator that this medication is blocking tumour growth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
finasteride
Arm Type
Experimental
Arm Description
finasteride 5mg po od from study entry to date of surgery
Intervention Type
Drug
Intervention Name(s)
finasteride 5mg oral daily
Primary Outcome Measure Information:
Title
Change in proliferation
Description
Patients will be followed from time of consent (around the time of consultation with a Thoracic Surgeon) to date of surgery (on average, approximately 4-6 weeks following Thoracic Surgeon consultation).
Time Frame
Original biopsy to surgical specimen (approx 6 weeks)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male age >18 biopsy-proven non-small cell lung cancer surgical intervention planned Exclusion Criteria: current use of 5-alpha reductase inhibitor previous diagnosis of prostate cancer previous hypersensitivity to 5-alpha reductase inhibitor
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1R9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

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