Back to resultsTrial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
Primary Purpose
Adenocarcinoma of the Prostate
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NanoPac®
Sponsored by
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring prostate cancer, prostatic neoplasms, genital neoplasms, male, urogenital neoplasms, prostatic diseases
Eligibility Criteria
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.
Sites / Locations
- University of Southern California
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
NanoPac® 6 mg/mL
NanoPac® 10 mg/mL
NanoPac® 15 mg/mL
Arm Description
NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Secondary Outcome Measures
Tumor Response Based on Change in Image Volume on mpMRI
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)
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
Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma
Concentration of Paclitaxel in the Systemic Circulation
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.
Full Information
NCT ID
NCT03077659
First Posted
February 28, 2017
Last Updated
July 29, 2019
Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03077659
Brief Title
Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
Official Title
Phase IIa Dose Escalation Trial of NanoPac® Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
October 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanOlogy, LLC
Collaborators
US Biotest, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate
Keywords
prostate cancer, prostatic neoplasms, genital neoplasms, male, urogenital neoplasms, prostatic diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NanoPac® 6 mg/mL
Arm Type
Experimental
Arm Description
NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
Arm Title
NanoPac® 10 mg/mL
Arm Type
Experimental
Arm Description
NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
Arm Title
NanoPac® 15 mg/mL
Arm Type
Experimental
Arm Description
NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume
Intervention Type
Drug
Intervention Name(s)
NanoPac®
Other Intervention Name(s)
Paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Description
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Time Frame
Day 1 to Day 29
Secondary Outcome Measure Information:
Title
Tumor Response Based on Change in Image Volume on mpMRI
Description
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.
Time Frame
Up to three months prior to consent and Day 29
Title
Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)
Description
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.
Time Frame
Screening and Day 29
Title
Percentage of Sample Considered Adenocarcinoma
Description
Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma
Time Frame
Day 29 (prostatectomy)
Title
Concentration of Paclitaxel in the Systemic Circulation
Description
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.
Time Frame
Day 1, Day 8, Day 15, Day 22, and Day 29
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelagh Verco, PhD
Organizational Affiliation
US Biotest, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
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