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

Completed · Phase 2 · Has a placebo group

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT02326454

Run by

Light Sciences Oncology

People needed

225

Starts

2014-11-01

Expected to finish

2017-03-29

Last updated by the study team

2018-08-08

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

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• For patients who have withdrawn from regularly taking their prescribed BPH medication, there should have been a 6 month washout period for 5-alpha reductase inhibitors and 3 months for other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:
• A bladder disease or condition co-exists, such as idiopathic over-active bladder (OAB) and is evaluated by the Investigator as the predominant etiology for the subject's voiding symptomatology. A score of 4 points or greater on the 3 item OAB Awareness Tool (OABV3) or a high rate of urinary frequency (>13xday and/or 4x/night) would require investigator specific evaluation in ascribing these symptoms to a bladder condition as opposed to lower urinary tract obstruction. i) If the former is the assessment, then the subject requires exclusion from the study. ii) If the latter is the assessment, then the subject may be deemed eligible for inclusion.
• 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.
• Requirements for daily incontinence pads or devices.
• Subjects in whom nocturia is due to etiologies other than their BPH-LUTS, such as neurogenic bladder, diabetic neuropathy, neurocongestive heart failure, hepatic failure, nephritic syndrome, sleep disorder.
• Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study i.e. unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months, or peripheral arterial disease with intermittent claudication or Leriche's syndrome.
• Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant.
• Unwilling to use contraception for 3 months following administration of study medication or with an interest in future fertility.
• A prolonged QTcF interval at baseline and/or who are currently taking medication that prolongs QT interval ("prolonged QTcF interval" defined as > 450 ms).
• Known sensitivity to porphyrin-type drugs or known history of porphyria.
• Any contraindications to use of the study treatment.
• Active alcohol or drug abuse.

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Anchorage, Alaska, United States
• Study site — Laguna Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Murrieta, California, United States
• Study site — San Diego, California, United States
• Study site — Tarzana, California, United States
• Study site — Denver, Colorado, United States
• Study site — Aventura, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Coral Gables, Florida, United States
• Study site — Pompano Beach, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Bloomington, Indiana, United States
• Study site — Greenwood, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Greenbelt, Maryland, United States
• Study site — Towson, Maryland, United States
• Study site — Chestnut Hill, Massachusetts, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Edison, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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