CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
NanoPac®drug
Likely dose
NanoPac® intratumoral injection (dose escalation study; specific dose not stated in protocol)AI-extracted
Key inclusion· 5
  • ✓Male, age ≥18 years
  • ✓Histopathologically confirmed prostate adenocarcinoma with Gleason grade ≥7, planned for radical prostatectomy
  • ✓Appropriate for paclitaxel therapy
  • ✓ECOG performance status 0 or 1
Key exclusion· 8
  • ✕Evidence of locally advanced or metastatic disease
  • ✕Prostate volume ≥50 cc
  • ✕Prior prostatectomy
  • ✕Prior local prostate treatment (radiation, brachytherapy, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03077659
NCT03077659Phase 2Completed
CompareCT.gov

Phase IIa Dose Escalation Trial of NanoPac® Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy

NanOlogy, LLC·interventional·Posted Mar 13, 2017·Updated Aug 20, 2019

In Brief

A Phase 2 clinical trial evaluating NanoPac® for Adenocarcinoma of the Prostate. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Open-label, dose rising, Phase IIa trial of intratumorally-injected NanoPac® 6, 10, or 15 mg/mL in subjects with prostate cancer scheduled for prostatectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Prostate
CountriesUnited States
CollaboratorsUS Biotest, Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 13, 2017
Enrollment StartSep 6, 2017
Primary CompletionOct 4, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.3 years ago

Interventions

NanoPac®drug

Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.