Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03081481

Run by

Sophiris Bio Corp

People needed

38

Starts

2017-06-07

Expected to finish

2019-04-05

Last updated by the study team

2019-04-10

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Vantage Health — Ocala, Florida, United States
• Chesapeake Urology Associates — Baltimore, Maryland, United States
• New York Urology Associates — New York, New York, United States
• Baylor Scott & White Memorial Hospital and Clinic — Temple, Texas, 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

Full record on ClinicalTrials.gov

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