Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Neoadjuvant Finasteride for Patients With Non-small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02055170
• Other study ID #: HLC001
• Status: Terminated
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: March 27, 2018

Study information

• Verified date: August 2018
• Source: CancerCare Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 27, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• finasteride 5mg oral daily

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
CancerCare Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)