Prostate Cancer Clinical Trial

Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

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.

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Full 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.

View Eligibility Criteria

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).

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT03081481

Recruitment Status:

Completed

Sponsor:

Sophiris Bio Corp

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There are 4 Locations for this study

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Vantage Health
Ocala Florida, 34474, United States
Chesapeake Urology Associates
Baltimore Maryland, 21204, United States
New York Urology Associates
New York New York, 10016, United States
Baylor Scott & White Memorial Hospital and Clinic
Temple Texas, 76508, United States
Princess Alexandra Hospital
Harlow , , United Kingdom
Imperial College
London , , United Kingdom
University College Hospital (UCLH)
London , , United Kingdom
University Hospital Southampton
Southampton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT03081481

Recruitment Status:

Completed

Sponsor:


Sophiris Bio Corp

How clear is this clinincal trial information?

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