Trial Outcomes & Findings for Trial of NanoPac Focal Therapy for Prostate Cancer (NCT NCT04221828)
NCT ID: NCT04221828
Last Updated: 2022-03-29
Results Overview
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
TERMINATED
PHASE2
1 participants
Day 1 to Day 85
2022-03-29
Participant Flow
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of NanoPac Focal Therapy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
NanoPac
n=1 Participants
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.
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.
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|---|---|
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Age, Continuous
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56 years
n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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PSA
|
5.4 ng/mL
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1 to Day 85Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Outcome measures
| Measure |
NanoPac
n=1 Participants
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.
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.
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events
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0 Participants
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SECONDARY outcome
Timeframe: Up to 2 weeks prior to Day 1 and Day 92Population: Data not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 weeks prior to Day 1 and Day 92Population: Data not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 month prior to Consent and Day 85Population: Data not collected
The proportion of subjects with local invasion as measured by mpMRI at the final study visit will be compared to screening (baseline)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 month prior to Consent and Day 85Population: Data not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 weeks prior to Day 1 and Day 85PSA 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)
Outcome measures
| Measure |
NanoPac
n=1 Participants
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.
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.
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|---|---|
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Change in PSA Density
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0 percent change in PSAD
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SECONDARY outcome
Timeframe: Up to 2 weeks prior to Day 1 and Day 85Population: Data not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 weeks prior to Day 1 and Day 92Population: Data not collected
Optional PSMA PET scan performed prior to first NanoPac injection and prior to prostatectomy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1, 8, 15, 29, 36, 43, 50, 57, 64, 71, and 85Population: Data not collected
Pharmacokinetic samples will be obtained on days of NanoPac injection and other clinic visits.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 15, 43, 57, and 85Population: Data not collected
Ejaculate samples will be collected for analysis of the presence or absence of paclitaxel.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 92Population: Data not collected
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
Outcome measures
Outcome data not reported
Adverse Events
NanoPac
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place