Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments nx-1207 2.5 mg, nx-1207 15 mg
Phase phase 2
Sponsor Nymox Corporation
Start date June 2012
End date April 2014
Trial size 150 participants
Trial identifier NCT01620515, NX03-0040

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer.
(Experimental)
nx-1207 2.5 mg
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
(Experimental)
nx-1207 15 mg
A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.

Primary Outcomes

Measure
Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.
time frame: Baseline to 45 days post-treatment
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.
time frame: Baseline to 60 days post-treatment

Secondary Outcomes

Measure
Change in tumor grade in the region of the baseline prostate cancer
time frame: Baseline to 45 days post-treatment
Change in tumor volume in the region of the baseline prostate cancer
time frame: Baseline to 45 days post-treatment
Change in tumor grade for the whole prostate
time frame: Baseline to 45 days post-treatment
Change in tumor volume in the whole prostate
time frame: Baseline to 45 days post-treatment

Eligibility Criteria

Male participants from 45 years up to 85 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Nymox Corporation.