Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH

Efficacy and Safety of a Single Transrectal Ultrasound(TRUS)-Guided Intraprostatic Injection of NX-1207 in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Phase III European Study

The purpose of the this international, multicenter, randomised, single-blind, parallel group, Phase III study is to demonstrate that a single transrectal ultrasound (TRUS)-guided intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in patients not adequately controlled by medical therapy with α-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score.

Inclusion Criteria:

• Signed informed consent;
• Age 45 or older;
• Medical history of LUTS/BPH
• Use of a marketed α-blocker for LUTS/BPH in the last 8 weeks;
• LUTS/BPH not adequately controlled by medical therapy with α-blockers;
• Presence of moderate-severe LUTS (IPSS ≥ 15) at screening and at baseline (after a 4 week run-in period with tamsulosin 0.4 mg QD);
• Prostate Volume ≥ 30 mL and ≤ 70 mL (as assessed by TRUS);
• Qmax < 15 mL/sec based on a minimum void of 125 mL;
• Agree not to use any other approved or experimental BPH or overactive bladder (OAB) medication anytime during the core study;
• Agree to perform follow-up visits even in case of oral treatment discontinuation before study end;
• Satisfactory compliance to run-in medication at Visit 2 (baseline).

Exclusion Criteria:

• Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment;
• Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months;
• PSA ≥ 10 ng/mL. In case of a PSA between 4.0 and 10.0 ng/mL, prostate cancer must have been ruled out to the satisfaction of the clinical Investigator by an historical biopsy;
• Prostate or bladder cancer, history of pelvic irradiation;
• Active or recurrent urinary tract infections (more than 1 episode in the last 12 months);
• History of neurogenic bladder or LUTS secondary to neurologic disease;
• Use of self-catheterization for urinary retention;
• Post-void residual urine volume > 200 mL;
• Haematuria which has not been appropriately evaluated to determine safe subject participation;
• Renal insufficiency (serum creatinine >2.0 mg/dL);
• Liver insufficiency (any liver function tests [LFTs]>2x upper limit of normal [ULN]);
• Poorly controlled diabetes (type 1 or type 2), as determined by HbA1c >6% and/or glycosuria;
• Any bleeding disorder such as haemophilia, clotting factor(s) deficiency or bleeding diathesis;
• Immunosuppressive disorders, such as Human Immunodeficiency (HIV) Virus, Acquired Immune Deficiency Syndrome (AIDS), lymphoproliferative disorders;
• Acute or chronic intestinal disease, such as ulcerative colitis, Crohn's disease, acute gastroenteritis in the run-in period; acute painful perianal disorder;
• Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, Percutaneous Transluminal Coronary Angioplasty (PTCA), congestive heart failure NYHA Class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months);
• Any condition that would interfere with the subject's ability to provide informed consent, to comply with study instructions, or that might confound the interpretation of the study results, such as dementia, psychosis, manic depressive disorder, post-traumatic stress disorder, stroke, Alzheimer's, depression, psychiatric illness, history or current evidence of drug or alcohol abuse within the last 12 months etc.;
• Participation in a study of any investigational drug or device within the previous 6 months;
• Hypersensitivity or contraindication to tamsulosin use;
• Use of prohibited medications that could endanger subjects performing the intraprostatic injection or that could interfere with the evaluation of study parameters;
• Men planning to have children in the future;
• Any other condition that may interfere with the study or endanger the subject.