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
1 other identifier
interventional
18
1 country
1
Brief Summary
To Evaluate Safety, Tolerability and Potential Efficacy of PRX302 effect on clinically significant localised low to intermediate prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started Jul 2015
Shorter than P25 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 27, 2016
July 1, 2016
11 months
June 30, 2015
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety and tolerability of a single injection of PRX302 in all patients will be assessed by recording Adverse Event assessments over 24 weeks
Week 24
Secondary Outcomes (1)
To evaluate the potential efficacy of PRX302 by • Transperineal targeted biopsy performed of the treated area at 24 weeks post-treatment
Week 24
Study Arms (1)
Intraprostatic administration
EXPERIMENTALPRX302
Interventions
Single prostate cancer lesion injected with PRX302.
Eligibility Criteria
You may qualify if:
- 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.
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 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLH
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hashim U Ahmed, PhD,FRCS
Division of Surgery & Interventional Science University College London
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2015
First Posted
July 16, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 27, 2016
Record last verified: 2016-07