Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT01620515
- Run by
- Nymox Corporation
- People needed
- 141
- Starts
- 2012-02-21
- Expected to finish
- 2015-10-21
- Last updated by the study team
- 2017-03-10
Who can join
Age: 45 and older, up to 85. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Tucson, Arizona, 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. — La Mesa, California, 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. — San Diego, California, 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. — New Britain, Connecticut, 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. — Naples, Florida, 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. — Shreveport, Louisiana, 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. — Baltimore, Maryland, 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. — Brick, New Jersey, 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. — Garden City, New York, 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. — Myrtle Beach, South Carolina, 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. — Carrollton, Texas, United States
- For information concerning this clinical site, please contact Nymox at 800-936-9669. — Salt Lake City, Utah, United States
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