Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03081481|
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : April 10, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: PRX302||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 7, 2017|
|Actual Primary Completion Date :||November 28, 2018|
|Actual Study Completion Date :||April 5, 2019|
Single prostate cancer lesion injected with PRX302
Other Name: Topsalysin
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 26 weeks post administration ]Treatment-emergent adverse events (TEAEs), including both serious and non-serious AEs, and assessments of severity and relatedness to both the study drug agent (PRX302) and the rest of the injection procedure
- 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] [ Time Frame: 24 weeks post administration ]Clinically significant disease is defined as Gleason 7, or in the presence of Gleason 3+3 a maximum cancer core length > 6 mm
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081481
|United States, Florida|
|Ocala, Florida, United States, 34474|
|United States, Maryland|
|Chesapeake Urology Associates|
|Baltimore, Maryland, United States, 21204|
|United States, New York|
|New York Urology Associates|
|New York, New York, United States, 10016|
|United States, Texas|
|Baylor Scott & White Memorial Hospital and Clinic|
|Temple, Texas, United States, 76508|
|Princess Alexandra Hospital|
|Harlow, United Kingdom|
|London, United Kingdom|
|University College Hospital (UCLH)|
|London, United Kingdom|
|University Hospital Southampton|
|Southampton, United Kingdom|
|Principal Investigator:||Hashim U Ahmed, MD||Imperial College London|
|Responsible Party:||Sophiris Bio Corp|
|Other Study ID Numbers:||
|First Posted:||March 16, 2017 Key Record Dates|
|Last Update Posted:||April 10, 2019|
|Last Verified:||April 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases