Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: finasteride 5mg oral daily

• Registration Number: NCT02055170
• Lead Sponsor: CancerCare Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-02
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-05
• Study Start: 2014-06
• Primary Completion: 2018-03-27
• Study Completion: 2018-03-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
finasteride	finasteride 5mg oral daily	finasteride 5mg po od from study entry to date of surgery

Primary Outcome Measures

Name	Time	Method
Change in proliferation	Original biopsy to surgical specimen (approx 6 weeks)	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).

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada