Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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|
- Change from baseline in the total IPSS score. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
- Effects on Lower Urinary Tract Symptoms [ Time Frame: 1,3,6,9 and 12 months ] [ Designated as safety issue: No ]
- Change from baseline in IPSS total score at 1, 3, 6 and 9 months;
- Change from baseline in IPSS subscores for storage symptoms;
- Change from baseline in IPSS subscores for voiding symptoms;
- Response rate by IPSS
- Effects on Quality of Life (QoL) due to urinary symptoms [ Time Frame: 1,3,6,9 and 12 months ] [ Designated as safety issue: No ]
- Change from baseline in IPSS subscore Quality of Life due to urinary symptoms;
- Change from baseline in BPH Impact Index
- Effects on general health related Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The change from baseline in the EQ-5D-5L questionnaire at 12 months or in case of early termination will be considered.
The EQ-5D-5L questionnaire is a standardised validated instrument for use as a measure of health outcome.
- Patient's global assessment of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
A patient-rated global assessment of treatment benefit, satisfaction and willingness to continue will be performed at 12 months (or in case of early termination) by using the BSW questionnaire.
The BSW is a validated questionnaire that consists of three, single-item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.
- Effects on maximum urinary flow rate (Qmax) [ Time Frame: 3,6,9 and 12 months ] [ Designated as safety issue: No ]To evaluate the effect on urinary flow, the change from baseline in maximum urinary flow (Qmax) at 3, 6, 9, 12 months will be considered. The same validated device and procedure will be used in all centres and a blinded centralized reading is foreseen.
- Effects on prostate volume [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]The change from baseline in TRUS assessed prostate volume at 3 and 12 months (or in case of early termination) will be considered.
- Long term follow-up evaluation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
The following data will be evaluated:
- Percentage of subjects requiring medical therapy, MIST, TURP or surgery for LUTS/BPH and time to treatment failure;
- Change from baseline in the total score of the IPSS;
- Change from baseline in QoL due to urinary symptoms
- Change from baseline in general health-related QoL (EQ-5D-5L);
- SAEs and episodes of acute urinary retention.
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
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.
Single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207
Active Comparator: 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
1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally (p.o.) QD
Please refer to this study by its ClinicalTrials.gov identifier: NCT02003742
|Contact: Federica Miottofirstname.lastname@example.org|
|Klinikum der Ludwig-Maximilians-universität München||Recruiting|
|Munich, Germany, 81377|
|Contact: Christian GRATZKE, MD|
|Principal Investigator: Christian GRATZKE, MD|
|Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele||Recruiting|
|Milan, Italy, 20132|
|Principal Investigator: Francesco Montorsi, MD|
|Niepubliczny Zaklad Opieki Zdrowotnej Specjalista||Recruiting|
|Kutno, Poland, 99-300|
|Contact: Piotr Humanski, Dr.|
|Principal Investigator: Piotr Humanski, MD|
|Hospital General Universitario Gregorio Marañón||Recruiting|
|Madrid, Spain, 28007|
|Contact: Carlos HERNÁNDEZ FERNÁNDEZ, MD|
|Principal Investigator: Carlos HERNÁNDEZ FERNÁNDEZ, MD|
|Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital||Recruiting|
|Sheffield, United Kingdom, S10 2JF|
|Contact: Christopher Re Chapple, BSc MD +44 07768902102 email@example.com|
|Contact: Susannah Hulton, RGN +44 0114 2711870 firstname.lastname@example.org|
|Principal Investigator: Christopher Re Chapple, Bsc MD|