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Trial of NanoPac Focal Therapy for Prostate Cancer

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Adenocarcinoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
Sponsored by
NanOlogy, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
    • Normal PT/INR and PTT;
  • ECOG of 0 or 1;
  • International Prostate Symptom Score (I-PSS) less than or equal to 20;
  • If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy;
  • Agree to all study procedures and provide signed informed consent;

Exclusion Criteria:

  • 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.

Sites / Locations

  • Moffitt Cancer Center
  • University of Kansas Medical Center
  • Henry Ford Health System
  • University of Missouri

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NanoPac

Arm Description

Direct 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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

Secondary Outcome Measures

Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
Prostate tissue samples obtained from a biopsy performed prior to baseline and prostatectomy. Histologic evaluation of these samples will be used to determine the Gleason score, and the results at baseline and Day 92 will be used to evaluate the tumor response to NanoPac. The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly; a higher Gleason score is likely to indicate a worse outcome. The Gleason score is used to help plan treatment and determine prognosis.
Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma
Tissues excised from the dominant lesion during prostatectomy (Day 92) will be evaluated for the percentage considered adenocarcinoma and compared to biopsy sample obtained at baseline.
Tumor Invasion Into Surrounding Tissues
The proportion of subjects with local invasion as measured by mpMRI at the final study visit will be compared to screening (baseline)
Tumor Response Based on Change in Image Volume on mpMRI
Tumor response to treatment with NanoPac will be determined by evaluating the change in image volume with multiparametric MRI (mpMRI) obtained prior to consent and again at the final study visit.
Change in PSA Density
PSA density (PSAD), is a calculation of the serum PSA level divided by the volume of the prostate gland. PSA density has been used as a prognostication tool in helping decide treatment approach. PSA density measured at the final study visit will be compared to screening (baseline)
Change in PI-RADS Score
The Prostate Imaging Reporting and Data System (PI-RADS) assessment uses a five-point scale based on the probability that a combination of mpMRI findings on T2 weighting (T2W), Diffusion Weighted Imaging (DWI), and Dynamic Contrast Enhancement (DCE) correlates with the presence of a clinically significant cancer in the prostate gland. A PI-RADS score of 1 is considered to be most probably benign and a score of 5 is considered to be highly suspicious of prostate malignancy. PI-RADS score will be measured at screening (baseline) and at the final study visit.
Effect on Tumor Presence in Lymph Nodes
Optional PSMA PET scan performed prior to first NanoPac injection and prior to prostatectomy
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Pharmacokinetic samples will be obtained on days of NanoPac injection and other clinic visits.
Presence or Absence of Paclitaxel in Ejaculate
Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.
Presence or Absence of Paclitaxel in Tissues Obtained at Prostatectomy
At the time of prostatectomy, available tissues including the tumor, the ipsilateral lobe of the prostate, the contralateral lobe of the prostate, and pelvic lymph nodes, will be evaluated for the presence or absence of paclitaxel

Full Information

First Posted
January 7, 2020
Last Updated
March 2, 2022
Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04221828
Brief Title
Trial of NanoPac Focal Therapy for Prostate Cancer
Official Title
Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.
Detailed Description
NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Adenocarcinoma, Prostatic Neoplasm, Urogenital Neoplasms, Genital Neoplasms, Male, Localized Cancer
Keywords
paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label, single group, safety, efficacy, and pharmacokinetic study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NanoPac
Arm Type
Experimental
Arm Description
Direct 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.
Intervention Type
Drug
Intervention Name(s)
NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension
Other Intervention Name(s)
paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events
Description
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Time Frame
Day 1 to Day 85
Secondary Outcome Measure Information:
Title
Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
Description
Prostate tissue samples obtained from a biopsy performed prior to baseline and prostatectomy. Histologic evaluation of these samples will be used to determine the Gleason score, and the results at baseline and Day 92 will be used to evaluate the tumor response to NanoPac. The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly; a higher Gleason score is likely to indicate a worse outcome. The Gleason score is used to help plan treatment and determine prognosis.
Time Frame
Up to 2 weeks prior to Day 1 and Day 92
Title
Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma
Description
Tissues excised from the dominant lesion during prostatectomy (Day 92) will be evaluated for the percentage considered adenocarcinoma and compared to biopsy sample obtained at baseline.
Time Frame
Up to 2 weeks prior to Day 1 and Day 92
Title
Tumor Invasion Into Surrounding Tissues
Description
The proportion of subjects with local invasion as measured by mpMRI at the final study visit will be compared to screening (baseline)
Time Frame
Up to 1 month prior to Consent and Day 85
Title
Tumor Response Based on Change in Image Volume on mpMRI
Description
Tumor response to treatment with NanoPac will be determined by evaluating the change in image volume with multiparametric MRI (mpMRI) obtained prior to consent and again at the final study visit.
Time Frame
Up to 1 month prior to Consent and Day 85
Title
Change in PSA Density
Description
PSA density (PSAD), is a calculation of the serum PSA level divided by the volume of the prostate gland. PSA density has been used as a prognostication tool in helping decide treatment approach. PSA density measured at the final study visit will be compared to screening (baseline)
Time Frame
Up to 2 weeks prior to Day 1 and Day 85
Title
Change in PI-RADS Score
Description
The Prostate Imaging Reporting and Data System (PI-RADS) assessment uses a five-point scale based on the probability that a combination of mpMRI findings on T2 weighting (T2W), Diffusion Weighted Imaging (DWI), and Dynamic Contrast Enhancement (DCE) correlates with the presence of a clinically significant cancer in the prostate gland. A PI-RADS score of 1 is considered to be most probably benign and a score of 5 is considered to be highly suspicious of prostate malignancy. PI-RADS score will be measured at screening (baseline) and at the final study visit.
Time Frame
Up to 2 weeks prior to Day 1 and Day 85
Title
Effect on Tumor Presence in Lymph Nodes
Description
Optional PSMA PET scan performed prior to first NanoPac injection and prior to prostatectomy
Time Frame
Up to 2 weeks prior to Day 1 and Day 92
Title
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Description
Pharmacokinetic samples will be obtained on days of NanoPac injection and other clinic visits.
Time Frame
Days 1, 8, 15, 29, 36, 43, 50, 57, 64, 71, and 85
Title
Presence or Absence of Paclitaxel in Ejaculate
Description
Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.
Time Frame
Days 15, 43, 57, and 85
Title
Presence or Absence of Paclitaxel in Tissues Obtained at Prostatectomy
Description
At the time of prostatectomy, available tissues including the tumor, the ipsilateral lobe of the prostate, the contralateral lobe of the prostate, and pelvic lymph nodes, will be evaluated for the presence or absence of paclitaxel
Time Frame
Day 92

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Normal PT/INR and PTT; ECOG of 0 or 1; International Prostate Symptom Score (I-PSS) less than or equal to 20; If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy; Agree to all study procedures and provide signed informed consent; Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelagh Verco, PhD
Organizational Affiliation
US Biotest, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial of NanoPac Focal Therapy for Prostate Cancer

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