Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - 85 |
| Updated: | 3/11/2017 |
| Start Date: | February 21, 2012 |
| End Date: | October 21, 2015 |
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
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.
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.
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.
We found this trial at
23
sites
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