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

NCT02003742 | Terminated Phase 3

• 1 other identifier: NX1207-IT-CL 0414
• Study Type: interventional
• Target: 104
• Locations: 5 countries
• Sites: 5

Brief Summary

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

LUTS; BPH

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the total IPSS score.

  The primary efficacy parameter is the change from baseline in the total score (Questions 1 to 7) of the IPSS at 12 months. The IPSS questionnaire will be filled by the subjects in blind conditions and will be reviewed by the investigators for its completeness. Validated local translations of the IPSS questionnaire will be used in each country.

  12 months

Secondary Outcomes (6)

• Effects on Lower Urinary Tract Symptoms

  1,3,6,9 and 12 months

• Effects on Quality of Life (QoL) due to urinary symptoms

  1,3,6,9 and 12 months

• Effects on general health related Quality of Life

  12 months

• Patient's global assessment of treatment

  12 months

• Effects on maximum urinary flow rate (Qmax)

  3,6,9 and 12 months

Other Outcomes (1)

• Long term follow-up evaluation

  24 months

Study Arms (2)

NX-1207

EXPERIMENTAL

Subjects randomised to the NX-1207 group will receive a single NX-1207 (2.5 mg) TRUS-guided intraprostatic injection (under antibiotic prophylaxis), followed by a placebo QD oral treatment for 12 months.

Drug: NX-1207

Comparator

ACTIVE COMPARATOR

Subjects randomised to the comparative arm will undergo TRUS only (under placebo prophylaxis) and will continue the tamsulosin 0.4 mg QD oral treatment for 12 months

Drug: Tamsulosin

Interventions

NX-1207 DRUG

Single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207

NX-1207

Tamsulosin DRUG

1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally (p.o.) QD

Comparator

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• RECORDATI GROUP: lead

Study Sites (5)

Klinikum der Ludwig-Maximilians-universität München

Munich, 81377, Germany

Location

Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele

Milan, 20132, Italy

Location

Niepubliczny Zaklad Opieki Zdrowotnej Specjalista

Kutno, 99-300, Poland

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

fexapotide; Tamsulosin

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: September 1, 2013
• Primary Completion: January 29, 2015
• Study Completion: January 29, 2015
• Last Updated: May 26, 2022

Record last verified: 2013-12

Locations

ES (1); GB (1); DE (1); PL (1); IT (1)