Clinical trial NCT01620515: Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Prostate Cancer
Localized Prostate Cancer
T1c Prostate Cancer
Focal Therapy
NX-1207
Lead sponsor: Nymox Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 141
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.
timeFrame: Baseline to 45 days post-treatment
measure: 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.
timeFrame: Baseline to 60 days post-treatment
Secondary outcomes:
measure: Change in tumor grade in the region of the baseline prostate cancer
timeFrame: Baseline to 45 days post-treatment
measure: Change in tumor volume in the region of the baseline prostate cancer
timeFrame: Baseline to 45 days post-treatment
measure: Change in tumor grade for the whole prostate
timeFrame: Baseline to 45 days post-treatment
measure: Change in tumor volume in the whole prostate
timeFrame: Baseline to 45 days post-treatment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Arizona
city: Atherton
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: La Mesa
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: Long Beach
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: San Diego
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: Denver
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Colorado
city: Englewood
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Colorado
city: New Britain
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Connecticut
city: Aventura
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Florida
city: Naples
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Florida
city: Jeffersonville
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Indiana
city: Shreveport
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Louisiana
city: Annapolis
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Maryland
city: Baltimore
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Maryland
city: Las Vegas
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Nevada
city: Brick
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Jersey
city: Albuquerque
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Mexico
city: Garden City
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New York
city: New York
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New York
city: Myrtle Beach
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: South Carolina
city: Germantown
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Tennessee
city: Carrollton
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
city: Salt Lake City
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Utah
Study officials:
References: