Trial of NanoPac Focal Therapy for Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04221828|
Recruitment Status : Terminated (Lack of enrollment)
First Posted : January 9, 2020
Last Update Posted : May 27, 2021
|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|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, single group, safety, efficacy, and pharmacokinetic study.|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy|
|Actual Study Start Date :||October 20, 2020|
|Actual Primary Completion Date :||January 27, 2021|
|Actual Study Completion Date :||February 8, 2021|
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 Name: paclitaxel
- Number of participants with treatment emergent adverse events [ Time Frame: Day 1 to Day 85 ]Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
- Tumor response based on histologic evaluation of biopsied prostate samples (Gleason Score) [ Time Frame: 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.
- Tumor response based on change in percentage of sample considered adenocarcinoma [ Time Frame: 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.
- Tumor invasion into surrounding tissues [ Time Frame: 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)
- Tumor response based on change in image volume on mpMRI [ Time Frame: 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.
- Change in PSA Density [ Time Frame: 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)
- Change in PI-RADS Score [ Time Frame: 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.
- Effect on tumor presence in lymph nodes [ Time Frame: 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
- Concentration of paclitaxel in the systemic circulation post-injection [ Time Frame: 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.
- Presence or absence of paclitaxel in ejaculate [ Time Frame: Days 15, 43, 57, and 85 ]Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.
- Presence or absence of paclitaxel in tissues obtained at prostatectomy [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221828
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65212|
|Study Director:||Shelagh Verco, PhD||US Biotest, Inc.|