Clinical trial · Interventional
Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NX-1207 15 mg | Drug | — | UNRESOLVED |
| NX-1207 2.5 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Active Surveillance
- description
- Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer.
- type
- EXPERIMENTAL
- label
- NX-1207 2.5 mg
- interventionNames
- Drug: NX-1207 2.5 mg
- type
- EXPERIMENTAL
- label
- NX-1207 15 mg
- interventionNames
- Drug: NX-1207 15 mg
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available