Benign Prostatic HyperplasiaPhase 1/2NCT00077012
Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia
A Phase 1/2 study testing QLT0074 and Photodynamic therapy in people with Benign Prostatic Hyperplasia, run by QLT Inc. at 7 sites in 2 countries.
Trial summary
The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074. Secondary objectives are: 1. To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia (BPH), evaluated by the American Urological… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- QLT0074 and Photodynamic therapy
- How many people
- Not given
- Where
- 7 sitesin 2 countries
- Study dates
- Mar 2003to May 2005
- Phase
- Phase 1/2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
- Twenty-seven men with symptomatic BPH despite adequate drug therapy and who are candidates for surgical or minimally invasive treatment will be enrolled in the study.
- Subjects must have an AUA SI >13, Qmax between 5 and 15 mL/sec, and a urethral treatment length between 30 and 65 mm (defined as the length of the urethra between the bladder neck and the edge of the verumontanum distal to the bladder).
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
North Texas Veteran Affairs Health Care System
Dallas, Texas, 75216
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Advanced Research Institute Inc
New Port Richey, Florida, 34652
Raymond Fay, MD, Inc
San Francisco, California, 94108
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Canada2 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
The Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5
About this study
Official title: A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Transurethral Photodynamic Therapy With QLT0074 for Benign Prostatic Hyperplasia
The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074.
Secondary objectives are:
- To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR).
- To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection.
- To select up to two transurethral PDT drug-light regimens for further clinical development.
Read the detailed description
This will be a multicenter, uncontrolled, dose escalation, exploratory study in subjects with symptomatic BPH. Six study centers are planned.
Each subject will receive a fixed dose of QLT0074 (0.4 mg) injected transurethrally into the prostate followed by transurethral light application to activate the drug. Five light dose cohorts will be investigated sequentially (25, 50, 80, 120, and 150 J/cm2), with 3 subjects in the first cohort and 6 subjects in cohorts 2-5 for a total of 27 subjects. The follow-up period for each subject is 180 days. There will be a minimum 30-day interval between treatment of the last subject in one cohort (Day 0) and treatment of the first subject in the next cohort to monitor predefined toxicities and ensure safety and tolerance in subjects of the previous cohort.
A Safety Monitoring Committee will evaluate toxicity related to PDT effects, and approve escalation of the light dose for each cohort. The light dose will not be escalated if any of the following predefined toxicity criteria occur and are judged to be related to a PDT effect by the Safety Monitoring Committee:
- 1 or more subjects in the cohort experience macroscopic urinary bleeding not resolved by Day 14, or
- 2 or more subjects in the cohort experience intolerable urinary pain not controlled with over-the-counter medication by Day 14, or
- 1 or more subjects in the cohort experience any other clinically significant urological adverse event, as judged by the Investigator and confirmed by the Safety Monitoring Committee.
In addition to the above events, the Safety Monitoring Committee will evaluate the incidence, timing, severity, and frequency of other adverse events and serious adverse events to assess the safety of transurethral PDT and the treatment procedures (such as the use of the cystoscope, InjectTx device, treatment balloon-catheter, etc).
To prevent treating subjects with a light dose greater than that which already provides substantial clinical benefit, the Safety Monitoring Committee will review preliminary efficacy data (AUA SI scores and Qmax values) after all subjects in a cohort (for each of the first 4 cohorts) have completed the Day 90 visit. Further enrollment will be curtailed if more than 75% of subjects in a cohort experience both of the following efficacy stopping criteria by Day 90:
- greater or equal to 75% reduction in the AUA SI score and,
- greater or equal to 100% increase in Qmax.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- QLT0074, Photodynamic therapy
- Keywords
- BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLT0074Drug
Photodynamic therapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2004 (estimated)
- Study startMar 2003
- Primary completionMay 2005
- Study completionMay 2005
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- QLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077012
- Sponsor's protocol ID
- BPH 002
- Status last verified
- May 2012
- First submitted
- 9 Feb 2004
- Last updated
- 23 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Transurethral Photodynamic Therapy With QLT0074 for Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00077012
- Acronym / sponsor ID
- BPH 002
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- QLT Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 11 Feb 2004 (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.
The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074.
Secondary objectives are:
- To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR).
- To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection.
- To select up to two transurethral PDT drug-light regimens for further clinical development.
Detailed description
This will be a multicenter, uncontrolled, dose escalation, exploratory study in subjects with symptomatic BPH. Six study centers are planned.
Each subject will receive a fixed dose of QLT0074 (0.4 mg) injected transurethrally into the prostate followed by transurethral light application to activate the drug. Five light dose cohorts will be investigated sequentially (25, 50, 80, 120, and 150 J/cm2), with 3 subjects in the first cohort and 6 subjects in cohorts 2-5 for a total of 27 subjects. The follow-up period for each subject is 180 days. There will be a minimum 30-day interval between treatment of the last subject in one cohort (Day 0) and treatment of the first subject in the next cohort to monitor predefined toxicities and ensure safety and tolerance in subjects of the previous cohort.
A Safety Monitoring Committee will evaluate toxicity related to PDT effects, and approve escalation of the light dose for each cohort. The light dose will not be escalated if any of the following predefined toxicity criteria occur and are judged to be related to a PDT effect by the Safety Monitoring Committee:
- 1 or more subjects in the cohort experience macroscopic urinary bleeding not resolved by Day 14, or
- 2 or more subjects in the cohort experience intolerable urinary pain not controlled with over-the-counter medication by Day 14, or
- 1 or more subjects in the cohort experience any other clinically significant urological adverse event, as judged by the Investigator and confirmed by the Safety Monitoring Committee.
In addition to the above events, the Safety Monitoring Committee will evaluate the incidence, timing, severity, and frequency of other adverse events and serious adverse events to assess the safety of transurethral PDT and the treatment procedures (such as the use of the cystoscope, InjectTx device, treatment balloon-catheter, etc).
To prevent treating subjects with a light dose greater than that which already provides substantial clinical benefit, the Safety Monitoring Committee will review preliminary efficacy data (AUA SI scores and Qmax values) after all subjects in a cohort (for each of the first 4 cohorts) have completed the Day 90 visit. Further enrollment will be curtailed if more than 75% of subjects in a cohort experience both of the following efficacy stopping criteria by Day 90:
- greater or equal to 75% reduction in the AUA SI score and,
- greater or equal to 100% increase in Qmax.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| QLT0074 | Drug | – |
| Photodynamic therapy | Drug | – |
Primary outcome
Not reported in the source record.
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 23 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QLT0074 and Photodynamic therapy in people with Benign Prostatic Hyperplasia, run by QLT Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 23 May 2012.