Benign Prostatic HyperplasiaPhase 2NCT02326454
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
A Phase 2 study testing talaporfin sodium, Saline and Drug Activator 100 J/cm in people with Benign Prostatic Hyperplasia, run by Light Sciences Oncology at 41 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- talaporfin sodium, Saline and Drug Activator 100 J/cm
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 41 sitesUnited States
- Study dates
- Nov 2014to 29 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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- For patients who have withdrawn from regularly taking their prescribed BPH medication, there should have been a 6 month washout period for 5-alpha reductase inhibitors and 3 months for other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).
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- 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
Who cannot join
- 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.
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- 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.
- Subject has clinical laboratory test results outside the reference ranges of the testing laboratory that are deemed to be clinically significant. Subjects with isolated test results that are outside the specified ranges and that are assessed as clinically insignificant will be allowed at the discretion of the Investigator, after discussion with the Sponsor's Medical Monitor/Study Physician, if appropriate. If a subject has 1 isolated test result outside the specific range that is deemed potentially clinically significant, rescreening may be allowed at the discretion of the Investigator, after discussion with the Medical Monitor/Study Physician
- Subjects with known disorders of coagulation, apart from those receiving anticoagulant / antithrombotic / antiplatelet therapy in whom the dose of such medication must have been stable for at least 1 month prior to randomisation. In those receiving Vitamin K antagonists (warfarin, acenocoumarol, phenindione, etc) the INR value at baseline should be <3.0.
- Inability or unwillingness to comply with the required photosensitivity precautions during the three weeks following study treatment.
- Subjects taking medications with a recognised propensity for causing photosensitivity (such as amiodarone, tetracyclines, sulphonamides) that cannot be discontinued for the initial study period, namely from 14 days prior to administration of study medication until 28 days afterwards.
- Subjects with medical or investigation results deemed unfit for study treatment, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study.
- Subjects who have received an investigational medicinal product within 30 days or 5 half-lives of the investigational product prior to study entry (defined as the start of the Screening Period).
- Subjects who are incapable of giving informed consent or complying with the protocol.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Study site
Albuquerque, New Mexico, 87109
Study site
Anchorage, Alaska, 99503
Study site
Anniston, Alabama, 36207
Study site
Aventura, Florida, 33180
Study site
Bala-Cynwyd, Pennsylvania, 19004
Study site
Bloomington, Indiana, 47403
Study site
Bradenton, Florida, 34205
Study site
Bryn Mawr, Pennsylvania, 19010
Study site
Chestnut Hill, Massachusetts, 02467
Study site
Cincinnati, Ohio, 45212
Study site
Concord, North Carolina, 28025
Study site
Coral Gables, Florida, 33146
Study site
Dallas, Texas, 75231
Study site
Denver, Colorado, 80220
Study site
Edison, New Jersey, 08837
Study site
Garden City, New York, 11530
Study site
Greenbelt, Maryland, 20770
Study site
Greenwood, Indiana, 46143
Study site
Houston, Texas, 77094
Study site
Huntsville, Alabama, 35801
Study site
Knoxville, Tennessee, 37923
Study site
Laguna Hills, California, 92653
Study site
Las Vegas, Nevada, 89144
Study site
Los Angeles, California, 90017
Study site
Middleburg Heights, Ohio, 44130
Study site
Mountlake Terrace, Washington, 98043
Study site
Murrieta, California, 92562
Study site
Myrtle Beach, South Carolina, 29572
Study site
New Orleans, Louisiana, 70006
Study site
New Orleans, Louisiana, 70115
Study site
New York, New York, 10016
Study site
Newburgh, New York, 12601
Study site
Pompano Beach, Florida, 33060
Study site
Poughkeepsie, New York, 12601
Study site
Salt Lake City, Utah, 84124
Study site
San Diego, California, 92120
Study site
Springfield, Oregon, 97477
Study site
St. Petersburg, Florida, 33710
Study site
Tampa, Florida, 33607
Study site
Tarzana, California, 91356
Study site
Towson, Maryland, 21204
About this study
Official title: A Phase 2 Randomised, Double-blind, Placebo Controlled, Study of MR901 in Patients With Moderate to Severe Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- talaporfin sodium, Saline, Drug Activator 100 J/cm, Drug Activator 200 J/cm
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talaporfin sodiumDrug
Also called LS11, NPe6, mono-(L)-aspartyl chlorin e6, ME2906
1 mg/kg
SalineDrug
Also called Placebo
Drug Activator 100 J/cmDevice
Also called Litx™ BPH Device
Light Dose: 100 J/cm
Drug Activator 200 J/cmDevice
Also called Litx™ BPH Device
Light Dose: 200 J/cm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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. Receives: Drug: Saline; Device: Drug Activator 200 J/cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptoms Score (IPSS) Questionnaire
Change from baseline in the total International Prostate Symptom Score (IPSS, Questions 1-7)
Measured: 12 weeks
Secondary outcomes (16)
Modified International Prostate Symptoms Score (IPSS) Questionnaire
Modified IPSS used to evaluate subject's average experience of symptoms over preceding 7 days.
Measured: 1, 2 and 3 Weeks
Patient Global Impression of Improvement (PGI-1)
The number of subjects in each of the 7 response categories will be collected by subject interview at all relevant time points
Measured: 4, 12, 26 and 52 weeks
Clinical Global Impression of Improvement (CGI-1)
The number of subjects in each of the 7 response categories will be assessed by the Investigator at all relevant time points.
Measured: 4, 12, 26 and 52 weeks
Maximum Urinary Flow Rate (Qmax)
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).
Measured: 1, 2, 3, 4, 12, 26 and 52 weeks
Post-void residual volume (PVR volume)
Measured post-voiding through insertion of a urinary catheter to complete bladder emptying, or measured by bladder ultrasound according to local standard practice.
Measured: 1, 2, 3, 4, 12, 26 and 52 weeks
3-Day Frequency/Volume Data
Data on urinary frequency and void volume will be collected by subjects for 3 days prior to each clinic visit
Measured: 1, 2, 3, 4, 12, 26 and 52 weeks
Safety and tolerability assessed by the number of subjects with Adverse Events
Assessed by variables such as AEs, laboratory parameters, vital signs, ECGs
Measured: 52 weeks
Prostate-specific Antigen (PSA)
As measured in serum, to detect any changes that may be caused by the effects of the therapeutic intervention under study on prostatic tissue.
Measured: 1, 2, 3, 4, 12, 26 and 52 weeks
Duration of effect/time to next treatment and treatment selected
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.
Measured: 52 weeks
International Index of Erectile Function-15 (IIEF-15)
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).
Measured: 4, 12, 26 and 52 weeks
Quality of Life evaluation - Bother Score
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').
Measured: 1, 2, 3, 4, 12, 26 and 52 weeks
Over-active Bladder-V3 (OAB-V3)
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).
Measured: 1, 2, 3, 4, 12, 26 and 52 weeks
International Prostate Symptoms Score (IPSS) Questionnaire
IPSS Total Score as Change from Baseline
Measured: 4, 26 and 52 weeks
IPSS Subscores.
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).
Measured: 1, 2, 3, 4, 12, 26 and 52 weeks
Prostate volume
As measured on TRUS, to detect any changes that may be caused by the effects of the therapeutic intervention under study on prostatic volume.
Measured: Baseline and 12 weeks
Quality of Life evaluation - BPH Impact Index (BPHII)
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).
Measured: 4, 12, 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startNov 2014
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Light Sciences Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mundipharma Research Limited
- Responsible party
- Sponsor
- Investigators
- Lisa Koch-Hulle, LSO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326454
- Sponsor's protocol ID
- MR901-2501
- Status last verified
- Aug 2018
- First submitted
- 16 Dec 2014
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomised, Double-blind, Placebo Controlled, Study of MR901 in Patients With Moderate to Severe Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT02326454
- Acronym / sponsor ID
- MR901-2501
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Light Sciences OncologyIndustry (pharma, biotech, devices)
- Collaborators
- Mundipharma Research Limited
- Study start
- Nov 2014
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Talaporfin sodium/Light dose 100 J/cm | Active comparator | Drug: talaporfin sodium, Device: Drug Activator 100 J/cmSingle 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 | Active comparator | Drug: talaporfin sodium, Device: Drug Activator 200 J/cmSingle 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 | Placebo comparator | Drug: Saline, Device: Drug Activator 100 J/cm0.9% 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 | Placebo comparator | Drug: Saline, Device: Drug Activator 200 J/cm0.9% Sodium Chloride is administered intravenously with Drug Activator 200 J/cm delivering light for 2 hours. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| talaporfin sodiumAlso: LS11, NPe6, mono-(L)-aspartyl chlorin e6, ME29061 mg/kg | Drug | Talaporfin sodium/Light dose 100 J/cm, Talaporfin sodium/Light dose 200 J/cm |
| SalineAlso: Placebo | Drug | Saline/Light dose 100 J/cm, Saline/Light dose 200 J/cm |
| Drug Activator 100 J/cmAlso: Litx™ BPH DeviceLight Dose: 100 J/cm | Device | Saline/Light dose 100 J/cm, Talaporfin sodium/Light dose 100 J/cm |
| Drug Activator 200 J/cmAlso: Litx™ BPH DeviceLight Dose: 200 J/cm | Device | Saline/Light dose 200 J/cm, Talaporfin sodium/Light dose 200 J/cm |
Primary outcome
International Prostate Symptoms Score (IPSS) Questionnaire
Time frame: 12 weeks
Change from baseline in the total International Prostate Symptom Score (IPSS, Questions 1-7)
16 secondary outcomes
Modified International Prostate Symptoms Score (IPSS) Questionnaire
Time frame: 1, 2 and 3 Weeks
Patient Global Impression of Improvement (PGI-1)
Time frame: 4, 12, 26 and 52 weeks
Clinical Global Impression of Improvement (CGI-1)
Time frame: 4, 12, 26 and 52 weeks
Maximum Urinary Flow Rate (Qmax)
Time frame: 1, 2, 3, 4, 12, 26 and 52 weeks
Post-void residual volume (PVR volume)
Time frame: 1, 2, 3, 4, 12, 26 and 52 weeks
3-Day Frequency/Volume Data
Time frame: 1, 2, 3, 4, 12, 26 and 52 weeks
Safety and tolerability assessed by the number of subjects with Adverse Events
Time frame: 52 weeks
Prostate-specific Antigen (PSA)
Time frame: 1, 2, 3, 4, 12, 26 and 52 weeks
Duration of effect/time to next treatment and treatment selected
Time frame: 52 weeks
International Index of Erectile Function-15 (IIEF-15)
Time frame: 4, 12, 26 and 52 weeks
Quality of Life evaluation - Bother Score
Time frame: 1, 2, 3, 4, 12, 26 and 52 weeks
Over-active Bladder-V3 (OAB-V3)
Time frame: 1, 2, 3, 4, 12, 26 and 52 weeks
International Prostate Symptoms Score (IPSS) Questionnaire
Time frame: 4, 26 and 52 weeks
IPSS Subscores.
Time frame: 1, 2, 3, 4, 12, 26 and 52 weeks
Prostate volume
Time frame: Baseline and 12 weeks
Quality of Life evaluation - BPH Impact Index (BPHII)
Time frame: 4, 12, 26 and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Koch-Hulle
LSO
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing talaporfin sodium, Saline and Drug Activator 100 J/cm in people with Benign Prostatic Hyperplasia, run by Light Sciences Oncology at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptoms Score (IPSS) Questionnaire (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.