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

NCT02326454 | Completed Phase 2

• 1 other identifier: MR901-2501
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 41

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptoms Score (IPSS) Questionnaire

  Change from baseline in the total International Prostate Symptom Score (IPSS, Questions 1-7)

  12 weeks

Secondary Outcomes (16)

• Modified International Prostate Symptoms Score (IPSS) Questionnaire

  1, 2 and 3 Weeks

• Patient Global Impression of Improvement (PGI-1)

  4, 12, 26 and 52 weeks

• Clinical Global Impression of Improvement (CGI-1)

  4, 12, 26 and 52 weeks

• Maximum Urinary Flow Rate (Qmax)

  1, 2, 3, 4, 12, 26 and 52 weeks

• Post-void residual volume (PVR volume)

  1, 2, 3, 4, 12, 26 and 52 weeks

Study Arms (4)

Talaporfin sodium/Light dose 100 J/cm

ACTIVE COMPARATOR

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

Drug: talaporfin sodium; Device: Drug Activator 100 J/cm

Talaporfin sodium/Light dose 200 J/cm

ACTIVE COMPARATOR

Single 1 mg/kg dose of talaporfin sodium is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours

Drug: talaporfin sodium; Device: Drug Activator 200 J/cm

Saline/Light dose 100 J/cm

PLACEBO COMPARATOR

0.9% Sodium Chloride is administered intravenously with Drug Activator 100 J/cm delivering light for 60 minutes of the 2-hour treatment period

Drug: Saline; Device: Drug Activator 100 J/cm

Saline/Light dose 200 J/cm

PLACEBO COMPARATOR

0.9% Sodium Chloride is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours.

Drug: Saline; Device: Drug Activator 200 J/cm

Interventions

talaporfin sodium DRUG

1 mg/kg

Also known as: LS11, NPe6, mono-(L)-aspartyl chlorin e6, ME2906, Laserphyrin, MR901is the combination of talaporfin sodium and the drug-activating device

Talaporfin sodium/Light dose 100 J/cm; Talaporfin sodium/Light dose 200 J/cm

Saline DRUG

Also known as: Placebo

Saline/Light dose 100 J/cm; Saline/Light dose 200 J/cm

Drug Activator 100 J/cm DEVICE

Light Dose: 100 J/cm

Also known as: Litx™ BPH Device

Saline/Light dose 100 J/cm; Talaporfin sodium/Light dose 100 J/cm

Drug Activator 200 J/cm DEVICE

Light Dose: 200 J/cm

Also known as: Litx™ BPH Device

Saline/Light dose 200 J/cm; Talaporfin sodium/Light dose 200 J/cm

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged ≥40 years, weighing ≤200 Kg and able to provide written, informed consent.
• Documented symptoms of BPH-LUTS for 6 months or more.
• For patients regularly taking their prescribed BPH medication, dose should have been stable for at least 6 months for 5-alpha reductase inhibitors and 3 months for other BPH medications.
• For patients who have withdrawn from regularly taking their prescribed BPH medication, there should have been a 6 month washout period for 5-alpha reductase inhibitors and 3 months for other BPH medications.
• Have a total International Prostate Symptom Score (IPSS; Qs 1-7) of ≥ 15 at both V1 and V2 with a difference between those visits of ≤ 4 points.
• Prostate volume of 30 - 80 mL (inclusive).
• Maximum urinary flow rate (Qmax): 5 - 15 mL/sec (assessed on two voids each of ≥ 150mL).
• Prostate-specific antigen (PSA) ≤10 ng/mL.
• Post-void residual (PVR) volume ≤200 mL measured by a urinary catheter or bladder ultrasound according to local standard practice.
• Prostatic urethral length (PUL) of between 30 - 55mm (inclusive) as measured by TRUS.
• Willing and able to comply with photosensitivity precautions

You may not qualify if:

• Any minimally invasive or surgical treatment within the last 12 months, and is not currently undergoing intraprostatic injections for BPH or any other prostatic condition. In any case, all enrolled subjects must have, at Baseline cystoscopy, an appearance/presentation of the prostate that is consistent with BPH and compatible with possible response to the study test treatment.
• Subjects weighing \>200 Kg.
• Subjects with a history or current evidence of any of the following:
• The subject eligibility explanation must be captured in the patient source documents.
• Active urinary tract infection i.e. must have a screening urinalysis without signs of infection or negative urine culture. Must not have had a previous symptomatic urinary tract infection within 4 weeks of the study.
• Urethral stricture or any other anatomical feature that would complicate catheterisation.
• Interstitial cystitis.
• Predominant prostate middle lobe, as determined by the Investigator.
• Prostate or bladder cancer or bladder carcinoma-in-situ - in particular, evidence from digital rectal exam (DRE) of prostate abnormalities suggestive of cancer in the last 12 months.
• Any other absolute indication for urosurgical intervention (such as acute or frequent retention, currently untreated bladder or urethral stones, urethral strictures/bladder neck contracture (BNC)).
• Damage to the bladder neck which could interfere with study procedures.
• PSA level in excess of \>10 ng/ml. If the PSA measurement is 2.5-10 ng/ml and/or has shown a clinically significant concerning increase in the last 6 months, local standard of care must be pursued to ensure the possibility of prostate cancer has been followed up and ruled out prior to study entry.
• Subjects who had had a prostate biopsy within 6 weeks prior to Screening.
• Any neurological condition affecting the bladder or a history of a neurogenic or chronically decompensated bladder i.e. neurogenic bladder, Parkinson's disease, history of chronic prostatitis within the last 5 years.
• Prior treatment for urinary incontinence.

Sponsors & Collaborators

• Light Sciences Oncology: lead
• Mundipharma Research Limited: collaborator

Study Sites (41)

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Anniston, Alabama, 36207, United States

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Huntsville, Alabama, 35801, United States

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Anchorage, Alaska, 99503, United States

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Laguna Hills, California, 92653, United States

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Los Angeles, California, 90017, United States

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Murrieta, California, 92562, United States

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San Diego, California, 92120, United States

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Tarzana, California, 91356, United States

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Denver, Colorado, 80220, United States

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Aventura, Florida, 33180, United States

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Bradenton, Florida, 34205, United States

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Coral Gables, Florida, 33146, United States

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Pompano Beach, Florida, 33060, United States

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St. Petersburg, Florida, 33710, United States

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Tampa, Florida, 33607, United States

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Bloomington, Indiana, 47403, United States

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Greenwood, Indiana, 46143, United States

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New Orleans, Louisiana, 70006, United States

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New Orleans, Louisiana, 70115, United States

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Greenbelt, Maryland, 20770, United States

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Towson, Maryland, 21204, United States

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Chestnut Hill, Massachusetts, 02467, United States

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Las Vegas, Nevada, 89144, United States

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Edison, New Jersey, 08837, United States

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Albuquerque, New Mexico, 87109, United States

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Garden City, New York, 11530, United States

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New York, New York, 10016, United States

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Newburgh, New York, 12601, United States

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Poughkeepsie, New York, 12601, United States

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Concord, North Carolina, 28025, United States

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Cincinnati, Ohio, 45212, United States

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Middleburg Heights, Ohio, 44130, United States

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Springfield, Oregon, 97477, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Bryn Mawr, Pennsylvania, 19010, United States

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Myrtle Beach, South Carolina, 29572, United States

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Knoxville, Tennessee, 37923, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77094, United States

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Salt Lake City, Utah, 84124, United States

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Mountlake Terrace, Washington, 98043, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Talaporfin; Sodium Chloride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lisa Koch-Hulle

  LSO

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 29, 2014
• Study Start: November 1, 2014
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

US (41)