Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : October 20, 2020
Actual Primary Completion Date : January 27, 2021
Actual Study Completion Date : February 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Paclitaxel

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 Name: paclitaxel




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. 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)

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
NanOlogy, LLC
US Biotest, Inc.
Investigators
Layout table for investigator information
Study Director: Shelagh Verco, PhD US Biotest, Inc.
Layout table for additonal information
Responsible Party: NanOlogy, LLC
ClinicalTrials.gov Identifier: NCT04221828    
Other Study ID Numbers: NANOPAC-2019-01
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Prostatic Neoplasms
Neoplasms
Adenocarcinoma
Urogenital Neoplasms
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action