Clinical trial NCT03081481: Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer
Official title: Multi-Centre, Ph IIb Study, Evaluating Safety & Efficacy of Targeted Intraprostatic Admin of PRX302 to Treat Men With Histologically Proven, Clinically Significant, Localised Prostate Cancer Associated With MRI Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Intraprostatic
MRI lesion
Prostate biopsies
Lead sponsor: Sophiris Bio Corp
Sponsor class: INDUSTRY
First posted: 2017-03-16
Enrollment: 38
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for the treatment of low to intermediate risk prostate cancer.

Detailed description: A multi-centre, open label, phase IIb study, evaluating the safety, tolerability and efficacy of a targeted intraprostatic focal administration in development. The study will treat approximately 40 men who meet the eligibility criteria, and give written consent. Safety and tolerability will be assessed post-treatment over 26 weeks. Efficacy will be assessed by biopsy and imaging (mpMRI) at 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Life expectancy ≥ 10 years.
* Serum prostate-specific antigen (PSA) ≤ 15ng/mL.
* A histologically proven, clinically significant lesion visible on mpMRI (magnetic resonance imaging) that is accessible to PRX302 transperineal injection.
* Radiological stage T1-T2 N0 Mx/M0 disease.
* Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.

Exclusion Criteria:

* Previous radiation therapy to the pelvis.
* Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
* Use of 5-alpha reductase inhibitor within the 3 months prior to dosing.
* Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
* Inability to tolerate transrectal ultrasound (TRUS).
* Known allergy to latex or gadolinium (Gd).
* Prior rectal surgery preventing insertion of the TRUS probe.
* Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate.
* Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc., likely to contribute significant artifact to images).

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 26 weeks post administration
Secondary outcomes:
measure: Proportion of patients with an absence of clinically significant prostate cancer in the targeted area at 24 weeks post-administration of PRX302, as determined by a transperineal targeted biopsy [Efficacy]
timeFrame: 24 weeks post administration
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Vantage Health
state: Florida
city: Baltimore
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: New York
country: United States
facility: New York Urology Associates
state: New York
city: Temple
country: United States
facility: Baylor Scott & White Memorial Hospital and Clinic
state: Texas
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
city: London
country: United Kingdom
facility: Imperial College
city: London
country: United Kingdom
facility: University College Hospital (UCLH)
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: Imperial College London
name: Hashim U Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: