Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: finasteride 5mg oral daily

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A1R9
      • Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: finasteride; finasteride 5mg po od from study entry to date of surgery	Drug: finasteride 5mg oral daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Original biopsy to surgical specimen (approx 6 weeks)

Collaborators and Investigators

• Sponsor: CancerCare Manitoba

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 27, 2018
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: February 2, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride
• Other Study ID Numbers: HLC001