Clinical trial · Interventional
Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer
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
NCT03081481CI-TRIAL-00038045completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRX302 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PRX302
- description
- intraprostatic administration
- interventionNames
- Drug: PRX302
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- 26 weeks post administration
- description
- 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
Secondary outcomes (1)
- 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]
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.