Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

NCT02055170 | Terminated Phase 2

• 1 other identifier: HLC001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

finasteride

EXPERIMENTAL

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

Drug: finasteride 5mg oral daily

Interventions

finasteride 5mg oral daily DRUG

finasteride

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CancerCare Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2014
• First Posted: February 5, 2014
• Study Start: June 1, 2014
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

CA (1)