Adenocarcinoma of the Prostate
Conditions
Keywords
prostate cancer, prostatic neoplasms, genital neoplasms, male, urogenital neoplasms, prostatic diseases
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.
Interventions
DRUGNanoPac®
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.
Sponsors
US Biotest, Inc.
NanOlogy, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) | Day 1 to Day 29 | Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Based on Change in Image Volume on mpMRI | 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) | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 4 weeks prior to prostatectomy. | 3 |
| 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 4 weeks prior to prostatectomy. | 3 |
| 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 4 weeks prior to prostatectomy. | 10 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | NanoPac® 6 mg/mL | Total | NanoPac® 15 mg/mL | NanoPac® 10 mg/mL |
|---|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 12.3 | 65.4 years STANDARD_DEVIATION 9 | 63.8 years STANDARD_DEVIATION 7.9 | 73.3 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 10 Participants | 7 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 13 Participants | 8 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 16 participants | 10 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 16 Participants | 10 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 10 |
| other Total, other adverse events | 3 / 3 | 2 / 3 | 6 / 10 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 10 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Time frame: Day 1 to Day 29
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NanoPac® 6 mg/mL | Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) | All TEAEs | 3 Participants |
| NanoPac® 6 mg/mL | Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) | Possibly Related TEAEs | 3 Participants |
| NanoPac® 10 mg/mL | Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) | Possibly Related TEAEs | 0 Participants |
| NanoPac® 10 mg/mL | Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) | All TEAEs | 2 Participants |
| NanoPac® 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) | Possibly Related TEAEs | 1 Participants |
| NanoPac® 15 mg/mL | Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) | All TEAEs | 6 Participants |
Secondary
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.
Time frame: Day 1, Day 8, Day 15, Day 22, and Day 29
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NanoPac® 6 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 1 hr Post-Injection | 5590.00 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 2312.336 |
| NanoPac® 6 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 2 hr Post-Injection | 3483.33 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 1851.657 |
| NanoPac® 6 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 4 hr Post-Injection | 2240.00 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 756.241 |
| NanoPac® 6 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 6 hr Post-Injection | 1926.67 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 823.549 |
| NanoPac® 6 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 8 | 177.10 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 102.777 |
| NanoPac® 6 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 15 | 65.10 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 24.974 |
| NanoPac® 6 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 22 | 55.70 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 15.556 |
| NanoPac® 6 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 29 | 35.45 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 14.496 |
| NanoPac® 10 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 4 hr Post-Injection | 4740.00 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 3889.884 |
| NanoPac® 10 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 22 | 43.05 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 16.051 |
| NanoPac® 10 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 6 hr Post-Injection | 5006.67 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 4938.181 |
| NanoPac® 10 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 8 | 234.33 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 73.446 |
| NanoPac® 10 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 15 | 82.85 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 7.283 |
| NanoPac® 10 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 1 hr Post-Injection | 19673.33 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 20736.445 |
| NanoPac® 10 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 2 hr Post-Injection | 9103.33 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 7881.982 |
| NanoPac® 10 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 29 | 54.75 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 36.275 |
| NanoPac® 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 4 hr Post-Injection | 6830.80 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 5219.617 |
| NanoPac® 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 2 hr Post-Injection | 12948.70 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 10230.061 |
| NanoPac® 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 1 hr Post-Injection | 19010.50 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 15105.857 |
| NanoPac® 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 1 - 6 hr Post-Injection | 5109.00 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 3544.025 |
| NanoPac® 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 22 | 86.63 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 52.358 |
| NanoPac® 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 15 | 106.11 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 62.626 |
| NanoPac® 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 8 | 404.25 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 221.326 |
| NanoPac® 15 mg/mL | Concentration of Paclitaxel in the Systemic Circulation | Day 29 | 57.64 Plasma paclitaxel concentration (pg/mL) | Standard Deviation 29.269 |
Secondary
Percentage of Sample Considered Adenocarcinoma
Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma
Time frame: Day 29 (prostatectomy)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NanoPac® 6 mg/mL | Percentage of Sample Considered Adenocarcinoma | Primary Tumor at Screening | 53.3 percentage of sample adenocarcinoma | Standard Deviation 5.8 |
| NanoPac® 6 mg/mL | Percentage of Sample Considered Adenocarcinoma | Primary Tumor at Day 29 | 25.0 percentage of sample adenocarcinoma | Standard Deviation 15 |
| NanoPac® 10 mg/mL | Percentage of Sample Considered Adenocarcinoma | Primary Tumor at Screening | 33.3 percentage of sample adenocarcinoma | Standard Deviation 24.7 |
| NanoPac® 10 mg/mL | Percentage of Sample Considered Adenocarcinoma | Primary Tumor at Day 29 | 56.7 percentage of sample adenocarcinoma | Standard Deviation 25.2 |
| NanoPac® 15 mg/mL | Percentage of Sample Considered Adenocarcinoma | Primary Tumor at Screening | 47.5 percentage of sample adenocarcinoma | Standard Deviation 22 |
| NanoPac® 15 mg/mL | Percentage of Sample Considered Adenocarcinoma | Primary Tumor at Day 29 | 42.5 percentage of sample adenocarcinoma | Standard Deviation 28 |
Secondary
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.
Time frame: Up to three months prior to consent and Day 29
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NanoPac® 6 mg/mL | Tumor Response Based on Change in Image Volume on mpMRI | Lesion Volume at Screening | 3.19 cc | Standard Deviation 1.46 |
| NanoPac® 6 mg/mL | Tumor Response Based on Change in Image Volume on mpMRI | Lesion Volume at Day 29 | 1.80 cc | Standard Deviation 0.98 |
| NanoPac® 10 mg/mL | Tumor Response Based on Change in Image Volume on mpMRI | Lesion Volume at Screening | 0.89 cc | Standard Deviation 0.44 |
| NanoPac® 10 mg/mL | Tumor Response Based on Change in Image Volume on mpMRI | Lesion Volume at Day 29 | 1.91 cc | Standard Deviation 1.5 |
| NanoPac® 15 mg/mL | Tumor Response Based on Change in Image Volume on mpMRI | Lesion Volume at Screening | 4.89 cc | Standard Deviation 5.12 |
| NanoPac® 15 mg/mL | Tumor Response Based on Change in Image Volume on mpMRI | Lesion Volume at Day 29 | 5.10 cc | Standard Deviation 7.79 |
Secondary
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.
Time frame: Screening and Day 29
Population: Full Analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NanoPac® 6 mg/mL | Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) | Gleason Score at Screening | 7.7 score on a scale | Standard Deviation 1.2 |
| NanoPac® 6 mg/mL | Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) | Gleason Score at Day 29 | 7.7 score on a scale | Standard Deviation 1.2 |
| NanoPac® 10 mg/mL | Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) | Gleason Score at Screening | 7.0 score on a scale | Standard Deviation 0 |
| NanoPac® 10 mg/mL | Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) | Gleason Score at Day 29 | 7.0 score on a scale | Standard Deviation 0 |
| NanoPac® 15 mg/mL | Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) | Gleason Score at Screening | 7.4 score on a scale | Standard Deviation 0.7 |
| NanoPac® 15 mg/mL | Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score) | Gleason Score at Day 29 | 7.1 score on a scale | Standard Deviation 0.9 |
Post Hoc
Change in PI-RADS Score
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 a prostate malignancy. PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present); PI-RADS 2: low (clinically significant cancer is unlikely to be present); PI-RADS 3: intermediate (presence of clinically significant cancer is equivocal); PI-RADS 4: high (clinically significant cancer is likely to be present); PI-RADS 5: very high (clinically significant cancer is highly likely to be present).
Time frame: Screening and Day 29
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NanoPac® 6 mg/mL | Change in PI-RADS Score | PI-RADS 3 : Screening | 1 Participants |
| NanoPac® 6 mg/mL | Change in PI-RADS Score | PI-RADS 5 : Screening | 2 Participants |
| NanoPac® 6 mg/mL | Change in PI-RADS Score | PI-RADS 4 : Screening | 0 Participants |
| NanoPac® 6 mg/mL | Change in PI-RADS Score | PI-RADS 4 : Day 29 | 1 Participants |
| NanoPac® 6 mg/mL | Change in PI-RADS Score | PI-RADS 5 : Day 29 | 2 Participants |
| NanoPac® 6 mg/mL | Change in PI-RADS Score | PI-RADS 3 : Day 29 | 0 Participants |
| NanoPac® 10 mg/mL | Change in PI-RADS Score | PI-RADS 4 : Screening | 1 Participants |
| NanoPac® 10 mg/mL | Change in PI-RADS Score | PI-RADS 3 : Screening | 1 Participants |
| NanoPac® 10 mg/mL | Change in PI-RADS Score | PI-RADS 5 : Day 29 | 1 Participants |
| NanoPac® 10 mg/mL | Change in PI-RADS Score | PI-RADS 3 : Day 29 | 0 Participants |
| NanoPac® 10 mg/mL | Change in PI-RADS Score | PI-RADS 4 : Day 29 | 2 Participants |
| NanoPac® 10 mg/mL | Change in PI-RADS Score | PI-RADS 5 : Screening | 1 Participants |
| NanoPac® 15 mg/mL | Change in PI-RADS Score | PI-RADS 5 : Screening | 4 Participants |
| NanoPac® 15 mg/mL | Change in PI-RADS Score | PI-RADS 4 : Day 29 | 2 Participants |
| NanoPac® 15 mg/mL | Change in PI-RADS Score | PI-RADS 3 : Day 29 | 2 Participants |
| NanoPac® 15 mg/mL | Change in PI-RADS Score | PI-RADS 3 : Screening | 1 Participants |
| NanoPac® 15 mg/mL | Change in PI-RADS Score | PI-RADS 4 : Screening | 5 Participants |
| NanoPac® 15 mg/mL | Change in PI-RADS Score | PI-RADS 5 : Day 29 | 6 Participants |
Post Hoc
Change in PSA Density
PSA density was measured with mpMRI
Time frame: Screening and Day 29
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NanoPac® 6 mg/mL | Change in PSA Density | PSA Density at Screening | 3.64 ng/mL/cc | Standard Deviation 5.75 |
| NanoPac® 6 mg/mL | Change in PSA Density | PSA Density at Day 29 | 1.95 ng/mL/cc | Standard Deviation 2.84 |
| NanoPac® 10 mg/mL | Change in PSA Density | PSA Density at Screening | 0.23 ng/mL/cc | Standard Deviation 0.02 |
| NanoPac® 10 mg/mL | Change in PSA Density | PSA Density at Day 29 | 0.20 ng/mL/cc | Standard Deviation 0.01 |
| NanoPac® 15 mg/mL | Change in PSA Density | PSA Density at Screening | 0.31 ng/mL/cc | Standard Deviation 0.31 |
| NanoPac® 15 mg/mL | Change in PSA Density | PSA Density at Day 29 | 0.20 ng/mL/cc | Standard Deviation 0.11 |
Post Hoc
Tumor Invasion Into Surrounding Tissues
Assessed histologically after TRUS biopsy at Screening and on Day 29 prior to prostatectomy.
Time frame: Screening and Day 29
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NanoPac® 6 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Screening? No | 1 Participants |
| NanoPac® 6 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Day 29? No | 1 Participants |
| NanoPac® 6 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Day 29? Yes | 2 Participants |
| NanoPac® 6 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Screening? Yes | 2 Participants |
| NanoPac® 10 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Day 29? Yes | 2 Participants |
| NanoPac® 10 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Day 29? No | 1 Participants |
| NanoPac® 10 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Screening? No | 3 Participants |
| NanoPac® 10 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Screening? Yes | 0 Participants |
| NanoPac® 15 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Day 29? No | 8 Participants |
| NanoPac® 15 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Screening? Yes | 4 Participants |
| NanoPac® 15 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Day 29? Yes | 2 Participants |
| NanoPac® 15 mg/mL | Tumor Invasion Into Surrounding Tissues | Any invasion at Screening? No | 6 Participants |