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Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03077659
Recruitment Status : Completed
First Posted : March 13, 2017
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
US Biotest, Inc.
Information provided by (Responsible Party):
NanOlogy, LLC

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 13, 2017
Results First Submitted Date  ICMJE July 2, 2019
Results First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE September 6, 2017
Actual Primary Completion Date October 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Day 1 to Day 29 ]
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Original Primary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
Incidence of Treatment Emergent Adverse Events (safety and tolerability) [ Time Frame: Up to Day 28 (time of prostatectomy) ]
Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • Tumor Response Based on Change in Image Volume on mpMRI [ Time Frame: Up to three months prior to consent and Day 29 ]
    Tumor response to treatment with NanoPac was determined by evaluating the change in image volume with multiparametric MRI (mpMRI) within three months prior to consent and again within 48 hours of the prostatectomy procedure (Day 29). In those cases where two dimensions/axes were available, width was imputed to height for the purposes of calculation, i.e. the lesion was assumed to be an oblate spheroid. In those cases where only one dimension/axis was available, that dimension/axis was imputed for all three dimensions i.e. the lesion was assumed to be a sphere. For this reason, analyses were performed for all subjects with two dimensions available, as well as those for which at least one dimension was available. The data presented for this outcome measure is the one dimension lesion volume calculation: Lesion Volume (cc) = (3.14/6)*(length)³, where length is the longer or only measured dimension.
  • Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) [ Time Frame: Screening and Day 29 ]
    Prostate tissue samples were obtained via biopsy at baseline and immediately prior to prostatectomy (Day 29). Histologic evaluation of these samples was used to determine the Gleason score, and the results at baseline and Day 29 were used to evaluate the tumor response to treatment with 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.
  • Percentage of Sample Considered Adenocarcinoma [ Time Frame: Day 29 (prostatectomy) ]
    Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma
  • Concentration of Paclitaxel in the Systemic Circulation [ Time Frame: Day 1, Day 8, Day 15, Day 22, and Day 29 ]
    Pharmacokinetic samples were taken on Day 1 at 1, 2, 4, and 6 hours post-injection, and weekly until prostatectomy. All numeric paclitaxel concentration data above the Lower Limit of Quantitation (25 pg/mL) was tabulated by cohort.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of NanoPac® [ Time Frame: Up to Day 28 (time of prostatectomy) ]
    Pharmacokinetic (PK) samples will be taken on Day 1 at 1, 2, 4, 8, and 24 hours post-injection, Day 3, Day 7, and weekly until prostatectomy (Day 28).
  • Pharmacokinetics: Peak plasma concentration (Cmax) of NanoPac® [ Time Frame: Up to Day 28 (time of prostatectomy) ]
    Pharmacokinetic (PK) samples will be taken on Day 1 at 1, 2, 4, 8, and 24 hours post-injection, Day 3, Day 7, and weekly until prostatectomy (Day 28).
  • Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of NanoPac® [ Time Frame: Up to Day 28 (time of prostatectomy) ]
    Pharmacokinetic (PK) samples will be taken on Day 1 at 1, 2, 4, 8, and 24 hours post-injection, Day 3, Day 7, and weekly until prostatectomy (Day 28).
  • Tumor Response Based on Change in Image Volume on mpMRI [ Time Frame: Baseline and Day 25 (3 days prior to prostatectomy) ]
    Tumor response to treatment with NanoPac® will be determined by evaluating the change in image volume with multiparametric MRI (mpMRI) at baseline and on Day 25 (3 days prior to scheduled prostatectomy)
  • Tumor response based on histologic evaluation of biopsied prostate samples [ Time Frame: Baseline and Day 28 (time of prostatectomy) ]
    Prostate tissue samples will be obtained via biopsy at baseline and immediately prior to prostatectomy (Day 28). Histologic evaluation of these samples will be used to evaluate the tumor response to treatment with NanoPac®.
  • Presence of tumor cells in tissues obtained at prostatectomy (Day 28) [ Time Frame: Day 28 (prostatectomy) ]
    Tissues excised during prostatectomy (Day 28) will be evaluated for the presence of tumor cells; tissues to be evaluated include the ipsilateral lobe of the prostate, the contralateral lobe of the prostate, and pelvic lymph nodes.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
Official Title  ICMJE Phase IIa Dose Escalation Trial of NanoPac® Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
Brief Summary Open-label, dose rising, Phase IIa trial of intratumorally-injected NanoPac® 6, 10, or 15 mg/mL in subjects with prostate cancer scheduled for prostatectomy.
Detailed Description

In this open-label, dose rising, Phase IIa trial with an expanded cohort at the dose of NanoPac® determined to have the best tolerability and safety profile, subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy. The study will include a dose escalation phase and a dose confirmation phase.

In the dose escalation phase, NanoPac® concentrations of 6, 10, and 15 mg/mL in an injection volume of 20% of the lobe of the prostate containing the dominant lesion will be studied in cohorts of 3, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data the next cohort may begin enrolling, or an additional 3 at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the DSMB, will enroll additional subjects to provide a cohort of 12 subjects at that dose level.

Tumor volume and serum prostate-specific antigen (PSA) will be determined prior to NanoPac® injection. Pharmacokinetic samples, PSA, and ejaculate will be collected in the interval between injection and prostatectomy. Imaging with mpMRI will be performed prior to NanoPac® injection and prior to prostatectomy. Prostate and pelvic lymph nodes excised at prostatectomy will be evaluated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Open-label, dose rising, Phase IIa trial. The study will include a dose escalation phase and a dose confirmation phase. In the dose escalation phase, NanoPac® concentrations of 6, 10, and 15 mg/mL in an injection volume of 20% of the lobe of the prostate containing the dominant lesion will be studied in cohorts of 3, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data the next cohort may begin enrolling, or an additional 3 at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the DSMB, will enroll additional subjects (dose confirmation phase) to provide a cohort of 12 subjects at that dose level.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma of the Prostate
Intervention  ICMJE Drug: NanoPac®
Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
Other Name: Paclitaxel
Study Arms  ICMJE
  • Experimental: NanoPac® 6 mg/mL
    NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
    Intervention: Drug: NanoPac®
  • Experimental: NanoPac® 10 mg/mL
    NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
    Intervention: Drug: NanoPac®
  • Experimental: NanoPac® 15 mg/mL
    NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
    Intervention: Drug: NanoPac®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2019)
16
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2017)
30
Actual Study Completion Date  ICMJE October 4, 2018
Actual Primary Completion Date October 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male; 18 years of age and older
  • Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned radical prostatectomy; appropriate for treatment with paclitaxel therapy
  • ECOG of 0 or 1
  • 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;
  • Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy
  • Willing to receive an mpMRI

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) prior to surgery
  • Treatment with a prior investigational agent within 30 days of first dose of investigational medication
  • Any previous local treatment of the prostate (i.e. radiation)
  • 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 medication components
  • History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077659
Other Study ID Numbers  ICMJE NANOPAC-2016-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NanOlogy, LLC
Study Sponsor  ICMJE NanOlogy, LLC
Collaborators  ICMJE US Biotest, Inc.
Investigators  ICMJE
Study Director: Shelagh Verco, PhD US Biotest, Inc.
PRS Account NanOlogy, LLC
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP