Trial · NCT00889707

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

NCT00889707, Phase 2, Completed, Sophiris Bio Corp; results first posted 2013-10-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia. Trials, record NCT00889707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00889707

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia
NCT number: NCT00889707
Status: Completed
Phases: Phase 2
Enrollment: 92 participants, actual
Lead sponsor: Sophiris Bio Corp
Conditions: Benign Prostatic Hyperplasia
Interventions: PRX302, Placebo
First posted: 2009-04-29
Last updated: 2018-11-21
Results first posted: 2013-10-28

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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)	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.
Secondary	Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)	3 months after treatment	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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)	3 months post-treatment	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.	score	MEAN
SECONDARY	Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)	3 months after treatment	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	ml/sec	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
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)	PRX302	-9.1	Standard Deviation 5.95	score
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)	Placebo	-5.8	Standard Deviation 5.40	score
Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)	PRX302	3.13	Standard Deviation 4.35	ml/sec
Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)	Placebo	1.31	Standard Deviation 3.16	ml/sec

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PRX302	61
Overall Study	STARTED	Placebo	31
Overall Study	COMPLETED	PRX302	54
Overall Study	COMPLETED	Placebo	21
Overall Study	NOT COMPLETED	PRX302	7
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Vertigo	Ear and labyrinth disorders	PRX302	4	61	4
other	Vertigo	Ear and labyrinth disorders	Placebo	3	31	3
other	Diarrhoea	Gastrointestinal disorders	PRX302	0	61	0
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	31	2
other	Arthralgia	Musculoskeletal and connective tissue disorders	PRX302	3	61	4
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	2	31	2
other	Headache	Nervous system disorders	PRX302	1	61	1
other	Headache	Nervous system disorders	Placebo	2	31	2
other	Anxiety	Psychiatric disorders	PRX302	0	61	0
other	Anxiety	Psychiatric disorders	Placebo	2	31	2

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PRX302
Total, all-cause mortality	Placebo
Total, other adverse events	PRX302	38	61
Total, other adverse events	Placebo	22	31
Total, serious adverse events	PRX302	1	61
Total, serious adverse events	Placebo	0	31

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
PRX302 vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00889707

GET https://conductscience.org/api/trials/v1/NCT00889707/events?page=2

API reference For AI assistants