Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase 2 Multicenter Prospective Open Label 2-Dose Level Clinical Safety and Efficacy Evaluation of Injection of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620515
• Other study ID #: NX03-0040
• Status: Completed
• Phase: Phase 2
• First received: June 13, 2012
• Last updated: March 9, 2017
• Start date: February 21, 2012
• Est. completion date: October 21, 2015

Study information

• Verified date: March 2017
• Source: Nymox Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 21, 2015
• Est. primary completion date: October 21, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• T1c prostate cancer

• Gleason score = 6 with no Gleason pattern of 4 or 5.

• Life expectancy = 5 years.

• Single positive prostate biopsy core with = 50% cancer

• PSA = 10 ng/mL

Exclusion Criteria:

• Previous active treatment (such as surgery, brachytherapy, radiotherapy) for prostate cancer.

• Evidence of metastatic disease or previous positive bone scan.

• Previous hormonal therapy for prostate cancer.

• Use of certain concomitant medications, including 5 alpha reductase inhibitors (e.g. finasteride, dutasteride), androgen receptor blockers (e.g. flutamide, bicalutamide), immunosuppressants(such as Imuran™, Enbrel™, Remicade™, Humira™, etc.), anticoagulants(such as Coumadin™ or heparin), or chemotherapeutics.

• Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months.

• Pelvic irradiation.

• Urinary tract infection more than once in the past 12 months.

• Acute or chronic prostatitis in the past 12 months.

• Clinically significant renal or hepatic impairment.

• Bleeding disorder.

• Poorly controlled diabetes type 1 or type 2.

• Urinary retention in the previous 12 months.

• Self-catheterization for urinary retention.

• Post-void residual urine volume > 200 mL.

• Prior significant rectal surgery or any rectal condition with rectal stenosis or fistula.

• History of alcohol or substance abuse or dependence within the past 2 years.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• NX-1207 2.5 mg
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
• NX-1207 15 mg
A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.

Locations

Country	Name	City	State
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Albuquerque	New Mexico
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Annapolis	Maryland
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Atherton	California
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Aventura	Florida
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Baltimore	Maryland
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Brick	New Jersey
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Carrollton	Texas
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Denver	Colorado
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Englewood	Colorado
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Garden City	New York
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Germantown	Tennessee
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Jeffersonville	Indiana
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	La Mesa	California
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Las Vegas	Nevada
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Long Beach	California
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Myrtle Beach	South Carolina
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Naples	Florida
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	New Britain	Connecticut
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	New York	New York
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Salt Lake City	Utah
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	San Diego	California
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Shreveport	Louisiana
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Nymox Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.	The primary efficacy endpoint is the percentage of subjects with undetectable prostate cancer (negative biopsy) in the region of the prostate where the baseline cancer was detected.	Baseline to 45 days post-treatment
Primary	Safety of a single treatment of NX-1207 2.5 mg or NX-1207 15 mg in subjects with biopsy-confirmed low grade low risk localized (T1c) prostate cancer.	Safety will be assessed by physical exam, prostate biopsy, monitoring of adverse events, changes in ECG, and changes in PSA and other clinical laboratory values.	Baseline to 60 days post-treatment
Secondary	Change in tumor grade in the region of the baseline prostate cancer		Baseline to 45 days post-treatment
Secondary	Change in tumor volume in the region of the baseline prostate cancer		Baseline to 45 days post-treatment
Secondary	Change in tumor grade for the whole prostate		Baseline to 45 days post-treatment
Secondary	Change in tumor volume in the whole prostate		Baseline to 45 days post-treatment