This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
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.
Moffitt Cancer Center
Tampa, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Missouri
Columbia, Missouri, United States
Number of Participants With Treatment Emergent Adverse Events
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Time frame: Day 1 to Day 85
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.
Time frame: Up to 2 weeks prior to Day 1 and Day 92
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.
Time frame: Up to 2 weeks prior to Day 1 and Day 92
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)
Time frame: Up to 1 month prior to Consent and Day 85
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.
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Time frame: Up to 1 month prior to Consent and Day 85
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)
Time frame: Up to 2 weeks prior to Day 1 and Day 85
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.
Time frame: Up to 2 weeks prior to Day 1 and Day 85
Effect on Tumor Presence in Lymph Nodes
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
Concentration of Paclitaxel in the Systemic Circulation Post-injection
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
Presence or Absence of Paclitaxel in Ejaculate
Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.
Time frame: Days 15, 43, 57, and 85
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
Time frame: Day 92