Phase 2
N=16
Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
Adenocarcinoma of the Prostate
Bottom Line
View on ClinicalTrials.gov: NCT03077659 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) — 3; 2; 6; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NanoPac® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- NanOlogy, LLC
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) |
3; 2; 6; 3; 0; 1 | — |
| SECONDARY Tumor Response Based on Change in Image Volume on mpMRI |
3.19; 0.89; 4.89; 1.80; 1.91; 5.10 | — |
| SECONDARY Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) |
7.7; 7.0; 7.4; 7.7; 7.0; 7.1 | — |
| SECONDARY Percentage of Sample Considered Adenocarcinoma |
53.3; 33.3; 47.5; 25.0; 56.7; 42.5 | — |
| SECONDARY Concentration of Paclitaxel in the Systemic Circulation |
5590.00; 19673.33; 19010.50; 3483.33; 9103.33; 12948.70 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male; 18 years of age and older
- Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
- ECOG of 0 or 1
- Laboratory requirements:
- WBC >2500/mm3
- Neutrophil >1500/mm3
- Hemoglobin >10 mg/dL
- Platelet >100,000/ mm3
- AST and ALT 5 years, with the exception of basal cell or squamous cell carcinoma.
Data sourced from ClinicalTrials.gov (NCT03077659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.