Trial Outcomes & Findings for Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia (NCT NCT00889707)

Last Updated: 2018-11-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

92 participants

Primary outcome timeframe

3 months post-treatment

Results posted on

2018-11-21

Participant Flow

Targeted patient enrollment was 90. 92 patients were actually randomized and dosed before enrollment was discontinued.

Participant milestones

Participant milestones
Measure	PRX302 0.6 microgram/gram prostate weight in 2% (weight/volume) human serum albumin (HSA)	Placebo 2% (weight/volume) human serum albumin (HSA) without PRX302
Overall Study STARTED	61	31
Overall Study COMPLETED	54	21
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Reasons for withdrawal
Measure	PRX302 0.6 microgram/gram prostate weight in 2% (weight/volume) human serum albumin (HSA)	Placebo 2% (weight/volume) human serum albumin (HSA) without PRX302
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	4	3
Overall Study Lost to Follow-up	0	2
Overall Study Lack of Efficacy	2	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRX302 n=61 Participants 0.6 microgram/gram prostate in 2% HSA	Placebo n=31 Participants 2% HSA without PRX302	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	17 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	14 Participants n=7 Participants	40 Participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 8.74 • n=5 Participants	63.5 years STANDARD_DEVIATION 8.36 • n=7 Participants	63.6 years STANDARD_DEVIATION 8.57 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	31 Participants n=7 Participants	92 Participants n=5 Participants
Region of Enrollment Canada	61 participants n=5 Participants	31 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post-treatment

Population: 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.

Outcome measures

Outcome measures
Measure	PRX302 n=52 Participants 0.6 microgram/gram prostate in 2% HSA	Placebo n=21 Participants 2% HSA without PRX302
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)	-9.1 score Standard Deviation 5.95	-5.8 score Standard Deviation 5.40

SECONDARY outcome

Timeframe: 3 months after treatment

Population: The protocol-defined efficacy evaluable (EE) 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

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.

Outcome measures

Outcome measures
Measure	PRX302 n=52 Participants 0.6 microgram/gram prostate in 2% HSA	Placebo n=21 Participants 2% HSA without PRX302
Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)	3.13 ml/sec Standard Deviation 4.35	1.31 ml/sec Standard Deviation 3.16

Adverse Events

PRX302

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PRX302 n=61 participants at risk 0.6 microgram/gram prostate in 2% HSA	Placebo n=31 participants at risk 2% HSA without PRX302
General disorders Medical Device Pain	1.6% 1/61 • Number of events 1 • 1 year	0.00% 0/31 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple Myeloma	1.6% 1/61 • Number of events 1 • 1 year	0.00% 0/31 • 1 year
Renal and urinary disorders Calculus Ureteric	1.6% 1/61 • Number of events 1 • 1 year	0.00% 0/31 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.6% 1/61 • Number of events 1 • 1 year	0.00% 0/31 • 1 year

Other adverse events

Other adverse events
Measure	PRX302 n=61 participants at risk 0.6 microgram/gram prostate in 2% HSA	Placebo n=31 participants at risk 2% HSA without PRX302
Ear and labyrinth disorders Vertigo	6.6% 4/61 • Number of events 4 • 1 year	9.7% 3/31 • Number of events 3 • 1 year
Gastrointestinal disorders Diarrhoea	0.00% 0/61 • 1 year	6.5% 2/31 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders Arthralgia	4.9% 3/61 • Number of events 4 • 1 year	6.5% 2/31 • Number of events 2 • 1 year
Nervous system disorders Headache	1.6% 1/61 • Number of events 1 • 1 year	6.5% 2/31 • Number of events 2 • 1 year
Psychiatric disorders Anxiety	0.00% 0/61 • 1 year	6.5% 2/31 • Number of events 2 • 1 year
Psychiatric disorders Insomnia	3.3% 2/61 • Number of events 2 • 1 year	9.7% 3/31 • Number of events 3 • 1 year
Renal and urinary disorders Dysuria	29.5% 18/61 • Number of events 18 • 1 year	6.5% 2/31 • Number of events 2 • 1 year
Renal and urinary disorders Haematuria	29.5% 18/61 • Number of events 18 • 1 year	35.5% 11/31 • Number of events 11 • 1 year
Renal and urinary disorders Micturition Urgency	23.0% 14/61 • Number of events 14 • 1 year	9.7% 3/31 • Number of events 3 • 1 year
Renal and urinary disorders Nocturia	3.3% 2/61 • Number of events 2 • 1 year	6.5% 2/31 • Number of events 2 • 1 year
Renal and urinary disorders Pollakiuria	24.6% 15/61 • Number of events 15 • 1 year	16.1% 5/31 • Number of events 5 • 1 year
Renal and urinary disorders Urinary Retention	0.00% 0/61 • 1 year	9.7% 3/31 • Number of events 3 • 1 year
Reproductive system and breast disorders Haematospermia	3.3% 2/61 • Number of events 2 • 1 year	6.5% 2/31 • Number of events 2 • 1 year
Reproductive system and breast disorders Perineal Pain	14.8% 9/61 • Number of events 9 • 1 year	0.00% 0/31 • 1 year
Reproductive system and breast disorders Prostatic Pain	1.6% 1/61 • Number of events 1 • 1 year	9.7% 3/31 • Number of events 3 • 1 year

Additional Information

Chief Medical Officer

Sophiris Bio Corp (formerly Protox Therapeutics)

Phone: 858-255-4711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigators will take all steps reasonably necessary to hold Protox's Proprietary Information in trust and confidence, will not use Proprietary Information in any manner or for any purpose not expressly set forth in their Agreement, and will not disclose any such Proprietary Information to any third party without first obtaining Protox's express written consent.
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Restriction type: OTHER