A Placebo Controlled Study of MR901 (Talaporfin Sodium Sodium + a Drug-activating Device) for the Relief of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Registration Number
- NCT02326454
- Lead Sponsor
- Light Sciences Oncology
- Brief Summary
This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium) activated by an intraurethrally placed drug-activating device. MR901 is a code used to identify the combination of talaporfin sodium and the drug-activating device. Two different light doses will be tested against placebo groups in this 4-arm study.
- Detailed Description
At least 192 patients with moderate-to-severe LUTS caused by BPH will be randomized in a 2:2:1:1 ratio to receive a single treatment of talaporfin sodium activated by light at one of two light doses or placebo (saline) with light at either dose. Follow-up is planned for 52 weeks from the day of treatment, with assessment at 12 weeks for change in International Prostate Symptom Score and continued follow-up during the remaining 40 weeks to assess duration of effect, need for any intervention, and longer-term safety.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 225
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Talaporfin sodium/Light dose 200 J/cm Drug Activator 200 J/cm Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours Saline/Light dose 100 J/cm Saline 0.9% Sodium Chloride is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period Saline/Light dose 100 J/cm Drug Activator 100 J/cm 0.9% Sodium Chloride is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period Saline/Light dose 200 J/cm Saline 0.9% Sodium Chloride is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours. Saline/Light dose 200 J/cm Drug Activator 200 J/cm 0.9% Sodium Chloride is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours. Talaporfin sodium/Light dose 100 J/cm talaporfin sodium Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period Talaporfin sodium/Light dose 100 J/cm Drug Activator 100 J/cm Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period Talaporfin sodium/Light dose 200 J/cm talaporfin sodium Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours
- Primary Outcome Measures
Name Time Method International Prostate Symptoms Score (IPSS) Questionnaire 12 weeks Change from baseline in the total International Prostate Symptom Score (IPSS, Questions 1-7)
- Secondary Outcome Measures
Name Time Method Quality of Life evaluation - BPH Impact Index (BPHII) 4, 12, 26 and 52 weeks The BPHII asks the subject to assess the impact of four aspects of their urinary condition over the previous 4 weeks, according to a 4-point (questions 1 - 3) or 5-point scale (question 4) (maximum score, 13).
Modified International Prostate Symptoms Score (IPSS) Questionnaire 1, 2 and 3 Weeks Modified IPSS used to evaluate subject's average experience of symptoms over preceding 7 days.
Patient Global Impression of Improvement (PGI-1) 4, 12, 26 and 52 weeks The number of subjects in each of the 7 response categories will be collected by subject interview at all relevant time points
Clinical Global Impression of Improvement (CGI-1) 4, 12, 26 and 52 weeks The number of subjects in each of the 7 response categories will be assessed by the Investigator at all relevant time points.
Prostate-specific Antigen (PSA) 1, 2, 3, 4, 12, 26 and 52 weeks As measured in serum, to detect any changes that may be caused by the effects of the therapeutic intervention under study on prostatic tissue.
Duration of effect/time to next treatment and treatment selected 52 weeks Subjects whose condition progresses such that an additional intervention is required during the 12-month study period may provide secondary evidence of efficacy, dependent upon their treatment allocation.
Maximum Urinary Flow Rate (Qmax) 1, 2, 3, 4, 12, 26 and 52 weeks The maximum rate at which urine can be voided, as measured using free uroflowmetry using two measurement 'runs' on two separate voids of at least 150mL each (where possible).
Post-void residual volume (PVR volume) 1, 2, 3, 4, 12, 26 and 52 weeks Measured post-voiding through insertion of a urinary catheter to complete bladder emptying, or measured by bladder ultrasound according to local standard practice.
3-Day Frequency/Volume Data 1, 2, 3, 4, 12, 26 and 52 weeks Data on urinary frequency and void volume will be collected by subjects for 3 days prior to each clinic visit
Safety and tolerability assessed by the number of subjects with Adverse Events 52 weeks Assessed by variables such as AEs, laboratory parameters, vital signs, ECGs
International Index of Erectile Function-15 (IIEF-15) 4, 12, 26 and 52 weeks 15-item, 5 domain scale collected by subject interview, relating to the subjects' experience of erectile function (and other sexual parameters) over the previous 4 weeks).
Quality of Life evaluation - Bother Score 1, 2, 3, 4, 12, 26 and 52 weeks Question 8 of the IPSS (also known as the Bother Score), which asks the subject to state how he would feel if he had to spend the rest of his life with his urinary condition just the way it is now, according to a 7-point scale (from 0 = 'delighted' to 6 = 'terrible').
Over-active Bladder-V3 (OAB-V3) 1, 2, 3, 4, 12, 26 and 52 weeks OAB symptoms will be assessed, by subject interview, using the 3-item OAB Awareness Tool (OAB-V3), under which the subject reports how much they have been bothered by 3 symptoms of OAB (without a specified time period) according to a 6-point scale ranging from 0 (not at all) to 5 (a very great deal) (maximum score, 15).
International Prostate Symptoms Score (IPSS) Questionnaire 4, 26 and 52 weeks IPSS Total Score as Change from Baseline
IPSS Subscores. 1, 2, 3, 4, 12, 26 and 52 weeks The changes from baseline for each of the 7 IPSS questions, as well as the totals for each of the 2 categories of symptoms - voiding symptoms (incomplete emptying, intermittency, weak stream, straining) and storage symptoms (frequency, urgency and nocturia).
Prostate volume Baseline and 12 weeks As measured on TRUS, to detect any changes that may be caused by the effects of the therapeutic intervention under study on prostatic volume.