Study Stopped
Lack of enrollment
Trial of NanoPac Focal Therapy for Prostate Cancer
Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
1 other identifier
interventional
1
1 country
4
Brief Summary
This study evaluates the use of NanoPac injected directly into the prostate lesion in men with 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 Oct 2020
Shorter than P25 for phase_2 prostate-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2021
CompletedResults Posted
Study results publicly available
March 29, 2022
CompletedMarch 29, 2022
March 1, 2022
3 months
January 7, 2020
January 25, 2022
March 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Day 1 to Day 85
Secondary Outcomes (10)
Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
Up to 2 weeks prior to Day 1 and Day 92
Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma
Up to 2 weeks prior to Day 1 and Day 92
Tumor Invasion Into Surrounding Tissues
Up to 1 month prior to Consent and Day 85
Tumor Response Based on Change in Image Volume on mpMRI
Up to 1 month prior to Consent and Day 85
Change in PSA Density
Up to 2 weeks prior to Day 1 and Day 85
- +5 more secondary outcomes
Study Arms (1)
NanoPac
EXPERIMENTALDirect injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.
Interventions
NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.
Eligibility Criteria
You may qualify if:
- At least 18 years of age;
- Histopathologically proven adenocarcinoma of the prostate:
- Localized cancer;
- Subjects with tumors classified as \<T3 per TNM classification, Gleason score≥ 6;
- Prostate tumor must be able to be visualized on mpMRI;
- Already considered to be candidate for radical prostatectomy;
- Considered appropriate for treatment with paclitaxel therapy;
- Laboratory requirements:
- WBC \>2500/mm3
- Neutrophil \>1500/mm3
- Hemoglobin \>10 mg/dL
- Platelet \>100,000/ mm3
- AST and ALT \<2.5 x ULN
- Total bilirubin \<1.5 x ULN
- Calculated creatinine clearance ≥ 30 ml/min
- +5 more criteria
You may not qualify if:
- Evidence of locally advanced or metastatic disease;
- Prostate size ≥ 50 cc;
- Prior prostatectomy, including surgery for any benign condition (such as TURP);
- Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
- Treatment with a prior investigational medication within 30 days of first dose of study agent;
- Any previous local treatment of the prostate (e.g. radiation, HIFU, cryotherapy, Focal Irreversible Electroporation, Photodynamic Therapy, Laser Induced Thermometry);
- Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule;
- Known sensitivity to any of the study agent components;
- History of prior malignancy that has not been in remission for \>5 years, with the exception of basal cell or squamous cell carcinoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NanOlogy, LLClead
- US Biotest, Inc.collaborator
Study Sites (4)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Missouri
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early due to lack of enrollment.
Results Point of Contact
- Title
- Gere S. diZerega, MD
- Organization
- US Biotest, Inc.
Study Officials
- STUDY DIRECTOR
Shelagh Verco, PhD
US Biotest, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 9, 2020
Study Start
October 20, 2020
Primary Completion
January 27, 2021
Study Completion
February 8, 2021
Last Updated
March 29, 2022
Results First Posted
March 29, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share