Benign Prostatic HyperplasiaPhase 2TRIUMPH-1NCT00889707

Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia

A Phase 2 study testing PRX302 in people with Benign Prostatic Hyperplasia, run by Sophiris Bio Corp at 9 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether PRX302 is safe and effective in the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH). Read more about this study

Who is it for?: Ages 40 to 80 years, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: PRX302
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 92 participants
Where: 9 sitesCanada
Study dates: Jan 2009to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Males aged 40 to 80 years;
Lower urinary tract symptoms (LUTS), such as frequency, nocturia, urgency, weak urine stream, hesitancy, intermittency or post-void dribbling attributable to BPH for at least 6 months prior to dosing;
Untreated, intolerant or refractory to α-blockers; should not have received the medication for at least 2 weeks prior to screening and 4 weeks prior to dosing;
Subjects with PSA values 4 - 10 ng/mL should be assessed or medical records checked (e.g. biopsy report) to rule out the presence of prostate cancer;
Untreated, intolerant or intolerant to 5-α reductase inhibitors AND must be off medication for at least 6 months prior to dosing;
IPSS of 15 or higher;
Prostate volume at screening estimated at 30 to 100 mL as determined by TRUS;
Provided written Informed Consent for participation in the study.

Who cannot join

Maximum urine flow rate (Qmax) of greater than 12 mL/sec;
Inability to void at least 150 mL of urine;
Post voiding residual urine volume (PVR) of greater than 200 mL;
Subjects unable to stand to void;
Subjects with acute or chronic bacterial prostatitis;
Using drugs (e.g. estrogen, androgen) that can produce androgen depression or anabolic steroids;

Show all 31Show fewer

Penile prosthesis or artificial urinary sphincter;
Presence of prostatic cyst larger than 1 cm in diameter;
Unwilling to use condoms for 3 weeks post-treatment to prevent pregnancy and to avoid semen contact with partner(s);
Urethral stricture disease;
Bladder neck abnormalities/strictures;
Significant median lobe hyperplasia that contributes to outflow obstruction;
Confirmed or suspected neurogenic bladder dysfunction;
Systemic neurological disorders that may affect voiding function;
Previous pelvic surgery, trauma or radiation;
Active genitourinary infection within 7 days before screening;
Significant renal dysfunction (as evidenced by a serum creatinine > 1.6 mg/dL on the screening laboratory evaluation);
Abnormal liver function as evidenced by any of the following abnormal laboratory values being greater than 1.5 upper limit of normal (ULN) at screening:
alkaline phosphatase (ALP);
total bilirubin;
alanine transferase (ALT); and/or
aspartate aminotransferase (AST);
Abnormal Prothrombin Time (PT > 13 sec) / International Normalized Ratio (INR > 1.2);
Severe cardiovascular or hepatic disease (American Society of Anesthesiologists [ASA] > 3); Presence of suspected or confirmed malignancy other than non-melanomatous, cutaneous malignancies which have undergone curative interventions;
Receiving anticoagulants (Subjects receiving anticoagulants may be enrolled after discontinuation of anticoagulant therapy and return of INR level to within normal limits (INR < 1.2) before dosing day. Subjects receiving platelet inhibitors (including garlic) must be off the inhibitors for at least 6 days or more. Subjects unable to discontinue anticoagulant therapy may not be enrolled in this study);
Subjects who have received any treatment for BPH other than α-blockers, 5-α reductase inhibitors or phytotherapy;
Subjects taking α-blockers and phytotherapy within 2 weeks of screening and 4 weeks of dosing;
Subjects receiving 5-α reductase inhibitors within 6 months of dosing;
Subjects taking part in other experimental programs prior to the start of the study or during the study period;
Any medical, psychological or other condition or medical history of the subject that, in the opinion of the Investigator or the Sponsor's Medical Monitor, unduly increases the risk of subject's participation or that would unnecessarily confound the data to be collected in this study;
Unable or unwilling to comply with the requirements of the protocol.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Canada9 sites

Bramalea Medical Centre
Brampton, Ontario, L6T 4S5
Brantford Urology Research
Brantford, Ontario, N3R 4N3
Urology Associates / Urology Medical Research
Kitchener, Ontario, N2N 2B9
McGill University Health Centre
Montreal, Quebec, H3A 2T5
The Fe/Male Health Centers
Oakville, Ontario, l6H 3P1
Andreou Research
Surrey, British Columbia, V3V 1N1
Anthony Skehan Medicine Professional Corp.
Thunder Bay, Ontario, P7E 6E7
CanMed Clinical Research Inc.
Victoria, British Columbia, V8T 5G1
Dr. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study of Transperineal Intraprostatic Injection of PRX302 for the Treatment of Benign Prostatic Hyperplasia

The purpose of this study is to determine whether PRX302 is safe and effective in the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).

Read the detailed description

This is a randomized, double-blinded, placebo-controlled study of transperineal intraprostatic injection of PRX302 under sonographic guidance. Subjects will be randomly assigned to the two treatment groups in a ratio of 2:1 between PRX302 and Placebo, stratified by prostate size and baseline IPSS.

Conditions: Benign Prostatic Hyperplasia
Being tested: PRX302, Placebo
Keywords: Benign Prostatic Hyperplasia, BPH, Enlarged Prostate
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRX302Drug
PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.
PlaceboDrug
PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.

Study groups in NCT00889707
Study group	Role	What they receive
Active Drug	Experimental	PRX302 Receives: Drug: PRX302
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline)
Total of 7 questions regarding lower urinary tract symptoms, with each question scored on a range of 0 (not at all) to 5 (almost always have the symptom). The total score is the summation of all 7 questions, and therefore has a possible range of 0 to 35.
Measured: 3 months post-treatment

Secondary outcomes (1)

Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)
A printout of uroflowmetry was provided to a central, blinded, independent reviewer for determination of the Qmax values to be used for evaluation of efficacy. The central, independent, blinded reviewer determined the Qmax from over-reads of the uroflowmetry printouts, applying the 2-second rule to reduce variability and increase the accuracy.
Measured: 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Sep 2010

First posted29 Apr 2009 (estimated)
Study startJan 2009
Primary completionDec 2009
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00889707
Sponsor's protocol ID: PRX302-2-03
Acronym: TRIUMPH-1
Status last verified: Oct 2018
First submitted: 27 Apr 2009
Last updated: 21 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study of Transperineal Intraprostatic Injection of PRX302 for the Treatment of Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT00889707
Acronym / sponsor ID: TRIUMPH-1 / PRX302-2-03
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia, BPH, Enlarged Prostate
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Sophiris Bio CorpIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Dec 2009 (actual)
Study completion: Sep 2010 (actual)
First posted: 29 Apr 2009 (estimated)
Results: Posted 28 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether PRX302 is safe and effective in the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Active Drug	Experimental	Drug: PRX302PRX302
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 40 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males aged 40 to 80 years;
Lower urinary tract symptoms (LUTS), such as frequency, nocturia, urgency, weak urine stream, hesitancy, intermittency or post-void dribbling attributable to BPH for at least 6 months prior to dosing;
Untreated, intolerant or refractory to α-blockers; should not have received the medication for at least 2 weeks prior to screening and 4 weeks prior to dosing;
Subjects with PSA values 4 - 10 ng/mL should be assessed or medical records checked (e.g. biopsy report) to rule out the presence of prostate cancer;
Untreated, intolerant or intolerant to 5-α reductase inhibitors AND must be off medication for at least 6 months prior to dosing;

Key exclusion criteria (31 listed)

Maximum urine flow rate (Qmax) of greater than 12 mL/sec;
Inability to void at least 150 mL of urine;
Post voiding residual urine volume (PVR) of greater than 200 mL;
Subjects unable to stand to void;
Subjects with acute or chronic bacterial prostatitis;

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
PRX302PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.	Drug	Active Drug
PlaceboPRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.	Drug	Placebo

Primary outcome

Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline)
Time frame: 3 months post-treatment
Total of 7 questions regarding lower urinary tract symptoms, with each question scored on a range of 0 (not at all) to 5 (almost always have the symptom). The total score is the summation of all 7 questions, and therefore has a possible range of 0 to 35.

1 secondary outcome

Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)
Time frame: 3 months after treatment

Results and safety

Results posted to the registry on 28 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRX302	61	54
Placebo	31	21

Primary outcome: Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline)

Time frame: 3 months post-treatment. Mean (Standard Deviation). Unit: score

Measure	PRX302 n = 52	Placebo n = 21
Value	-9.1 (5.95)	-5.8 (5.40)

PRX302 vs Placebo: p = 0.040, ANCOVA

Population analysed: The efficacy evaluable (EE) protocol defined primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PRX302	1 of 61 (1.6%)	38 of 61 (62.3%)	Not reported
Placebo	0 of 31 (0%)	22 of 31 (71%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

Peter Pommerville, MD principal investigator

CanMed Clinical Reaearch Inc.

Mostafa Elhilali, MD principal investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

9 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 PRX302 in people with Benign Prostatic Hyperplasia, run by Sophiris Bio Corp at 9 sites in Canada.

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 8 inclusion and 31 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in 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. 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?

Yes. Results are posted in the registry (first posted 28 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline) (time frame: 3 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00889707.

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 21 Nov 2018.