Trial of NanoPac Focal Therapy for Prostate Cancer

• Sponsor: NanOlogy, LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04221828
• Collaborator: US Biotest, Inc. (Industry)
• Enrollment: 1
• Locations: 4
• Arm: 1
• Actual Duration (Months): 3.6
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Adenocarcinoma; Prostatic Neoplasm; Urogenital Neoplasms; Genital Neoplasms, Male; Localized Cancer	Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open-label, single group, safety, efficacy, and pharmacokinetic study.Open-label, single group, safety, efficacy, and pharmacokinetic study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
• Actual Study Start Date: Oct 20, 2020
• Actual Primary Completion Date: Jan 27, 2021
• Actual Study Completion Date: Feb 8, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: NanoPac 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.

Drug: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension; 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.; Other Names: paclitaxel

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events [Day 1 to Day 85]

   Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

Secondary Outcome Measures

1. Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) [Up to 2 weeks prior to Day 1 and Day 92]

   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.

2. Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma [Up to 2 weeks prior to Day 1 and Day 92]

   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.

3. Tumor Invasion Into Surrounding Tissues [Up to 1 month prior to Consent and Day 85]

   The proportion of subjects with local invasion as measured by mpMRI at the final study visit will be compared to screening (baseline)

4. Tumor Response Based on Change in Image Volume on mpMRI [Up to 1 month prior to Consent and Day 85]

   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.

5. Change in PSA Density [Up to 2 weeks prior to Day 1 and Day 85]

   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)

6. Change in PI-RADS Score [Up to 2 weeks prior to Day 1 and Day 85]

   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.

7. Effect on Tumor Presence in Lymph Nodes [Up to 2 weeks prior to Day 1 and Day 92]

   Optional PSMA PET scan performed prior to first NanoPac injection and prior to prostatectomy

8. Concentration of Paclitaxel in the Systemic Circulation Post-injection [Days 1, 8, 15, 29, 36, 43, 50, 57, 64, 71, and 85]

   Pharmacokinetic samples will be obtained on days of NanoPac injection and other clinic visits.

9. Presence or Absence of Paclitaxel in Ejaculate [Days 15, 43, 57, and 85]

   Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.

10. Presence or Absence of Paclitaxel in Tissues Obtained at Prostatectomy [Day 92]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612
2	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
3	Henry Ford Health System	Detroit	Michigan	United States	48202
4	University of Missouri	Columbia	Missouri	United States	65212

Sponsors and Collaborators

• NanOlogy, LLC
• US Biotest, Inc.

Investigators

• Study Director: Shelagh Verco, PhD, US Biotest, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 8, 2020

More Information

Publications

None provided.

• Responsible Party: NanOlogy, LLC
• ClinicalTrials.gov Identifier: NCT04221828
• Other Study ID Numbers: NANOPAC-2019-01
• First Posted: Jan 9, 2020
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NanOlogy, LLC: paclitaxel
• Additional relevant MeSH terms: Prostatic Neoplasms; Neoplasms; Adenocarcinoma; Urogenital Neoplasms; Genital Neoplasms, Male; Paclitaxel; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Overall Participants	1
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	56
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	1 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 100%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
PSA (ng/mL) [Number]
Number [ng/mL]	5.4

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	1
Count of Participants [Participants]	0 0%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	1
Number [percent change in PSAD]	0

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
Measure Participants	0

Adverse Events

Time Frame	Day 1 to Day 85
Arm/Group Title	NanoPac
Arm/Group 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. NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension: 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.
All Cause Mortality
	NanoPac
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	NanoPac
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	NanoPac
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

Study was terminated early due to lack of enrollment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.