Clinical trial · Interventional
Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer
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
NCT02499848CI-TRIAL-00023255completedPhase 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)
To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate 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
- Intraprostatic administration
- description
- PRX302
- interventionNames
- Drug: PRX302
Primary outcomes (1)
- 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 (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.