Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

Nymox

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: NX-1207 15 mg; Drug: NX-1207 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01620515

NX03-0040

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: Male

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 3 patient groups

Active Surveillance

No Intervention group

Description:

Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer.

NX-1207 2.5 mg

Experimental group

Treatment:

Drug: NX-1207 2.5 mg

NX-1207 15 mg

Experimental group

Treatment:

Drug: NX-1207 15 mg