Clinical trial NCT02499848: Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer
Official title: Phase IIa Study, Evaluating the Safety and Tolerability of Targeted Intraprostatic Administration of PRX302 With Histologically Proven,Clinically Significant Localised, Low to Intermediate Risk Prostate Cancer Associated With MRI Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: MRI Lesion
transperineal injection
prostate biopsies
Lead sponsor: Sophiris Bio Corp
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 18
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: To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.

Detailed description: A single center, open label, Phase IIa, Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) prospective development study. The study will treat approximately 20 men who meet the eligibility criteria, and give written informed consent. Safety and Tolerability will be assessed post-treatment at 2 days (phone call), 2 weeks, 6 weeks, 12 weeks, 24 weeks and 26 weeks. Potential Efficacy will be assessed by biopsy at 24 weeks and imaging (MRI) at 2 weeks, 12 weeks and 24 weeks and PSA outcomes at 12 and 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Men aged ≥40 years and life expectancy of ≥10 years.
* Serum prostate-specific antigen (PSA) ≤15 ng/mL.
* Transperineal prostate biopsy within 12 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.
* Radiological stage T1-T2 N0 Mx/M0 disease.
* A visible lesion on mpMRI that is accessible to PRX302 transperineal injection.

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 a 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 a transrectal ultrasound (TRUS).
* Known allergy to latex or gadolinium (Gd).
* Previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, 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: safety and tolerability of a single injection of PRX302 in all patients will be assessed by recording Adverse Event assessments over 24 weeks
timeFrame: Week 24
Secondary outcomes:
measure: To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment
timeFrame: Week 24
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCLH
Study officials:
affiliation: Division of Surgery & Interventional Science University College London
name: Hashim U Ahmed, PhD,FRCS
role: PRINCIPAL_INVESTIGATOR
References: