Clinical Trials /

Trial of NanoPac Focal Therapy for Prostate Cancer

NCT04221828

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: NANOPAC-2019-01
  • NCT ID: NCT04221828

Conditions

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Cancer Adenocarcinoma
  • Prostatic Neoplasm
  • Urogenital Neoplasms
  • Genital Neoplasms, Male
  • Localized Cancer

Interventions

DrugSynonymsArms
NanoPac (sterile nanoparticulate paclitaxel) Powder for SuspensionpaclitaxelNanoPac

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
NanoPacExperimentalDirect 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

Eligibility Criteria

        Inclusion Criteria:

          -  At least 18 years of age;

          -  Histopathologically proven adenocarcinoma of the prostate:

               -  Localized cancer;

               -  Patients with tumors classified as <T3 per TNM classification, Gleason grade ≥ 6;

          -  Prostate tumor must be able to be visualized on mpMRI;

          -  Considered to be candidate for radical prostatectomy and 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

               -  Creatinine <2 mg/dL

               -  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;

          -  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 patient'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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment emergent adverse events
Time Frame:Day 1 to Day 85
Safety Issue:
Description:Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:Prostate tissue samples obtained during biopsy at 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.
Measure:Tumor response based on change in percentage of sample considered adenocarcinoma
Time Frame:Up to 2 weeks prior to Day 1 and Day 92
Safety Issue:
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.
Measure:Tumor invasion into surrounding tissues
Time Frame:Up to 1 month prior to Consent and Day 85
Safety Issue:
Description:The proportion of subjects with local invasion as measured by mpMRI at the final study visit will be compared to screening (baseline)
Measure:Tumor response based on change in image volume on mpMRI
Time Frame:Up to 1 month prior to Consent and Day 85
Safety Issue:
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.
Measure:Change in PSA Density
Time Frame:Up to 2 weeks prior to Day 1 and Day 85
Safety Issue:
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)
Measure:Change in PI-RADS Score
Time Frame:Up to 2 weeks prior to Day 1 and Day 85
Safety Issue:
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.
Measure:Effect on tumor presence in lymph nodes
Time Frame:Up to 2 weeks prior to Day 1 and Day 92
Safety Issue:
Description:PSMA PET scan performed prior to first NanoPac injection and prior to prostatectomy
Measure:Concentration of paclitaxel in the systemic circulation post-injection
Time Frame:Days 1, 8, 15, 29, 36, 43, 50, 57, 64, 71, and 85
Safety Issue:
Description:Pharmacokinetic samples will be obtained on days of NanoPac injection and other clinic visits.
Measure:Presence or absence of paclitaxel in ejaculate
Time Frame:Days 15, 43, 64, and 85
Safety Issue:
Description:Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.
Measure:Presence or absence of paclitaxel in tissues obtained at prostatectomy
Time Frame:Day 92
Safety Issue:
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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NanOlogy, LLC

Trial Keywords

  • paclitaxel

Last Updated

July 6, 2020