Trial Outcomes & Findings for Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer (NCT NCT03077659)

NCT ID: NCT03077659

Last Updated: 2019-08-20

Results Overview

Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Day 1 to Day 29

Results posted on

2019-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	3	3	10
Overall Study COMPLETED	3	3	9
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NanoPac® 6 mg/mL n=3 Participants 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.	NanoPac® 10 mg/mL n=3 Participants 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.	NanoPac® 15 mg/mL n=10 Participants 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.	Total n=16 Participants Total of all reporting groups
Age, Continuous	63.0 years STANDARD_DEVIATION 12.3 • n=5 Participants	73.3 years STANDARD_DEVIATION 7.8 • n=7 Participants	63.8 years STANDARD_DEVIATION 7.9 • n=5 Participants	65.4 years STANDARD_DEVIATION 9.0 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants	16 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 29

Population: Full Analysis Set

Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.

Outcome measures

Outcome measures
Measure	NanoPac® 6 mg/mL n=3 Participants NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 10 mg/mL n=3 Participants NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 15 mg/mL n=10 Participants NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) All TEAEs	3 Participants	2 Participants	6 Participants
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) Possibly Related TEAEs	3 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to three months prior to consent and Day 29

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	NanoPac® 6 mg/mL n=3 Participants NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 10 mg/mL n=3 Participants NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 15 mg/mL n=9 Participants NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.
Tumor Response Based on Change in Image Volume on mpMRI Lesion Volume at Screening	3.19 cc Standard Deviation 1.46	0.89 cc Standard Deviation 0.44	4.89 cc Standard Deviation 5.12
Tumor Response Based on Change in Image Volume on mpMRI Lesion Volume at Day 29	1.80 cc Standard Deviation 0.98	1.91 cc Standard Deviation 1.50	5.10 cc Standard Deviation 7.79

SECONDARY outcome

Timeframe: Screening and Day 29

Population: Full Analysis set

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.

Outcome measures

Outcome measures
Measure	NanoPac® 6 mg/mL n=3 Participants NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 10 mg/mL n=3 Participants NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 15 mg/mL n=10 Participants NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.
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	7.0 score on a scale Standard Deviation 0.0	7.1 score on a scale Standard Deviation 0.9
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	7.0 score on a scale Standard Deviation 0.0	7.4 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Day 29 (prostatectomy)

Population: Full Analysis Set

Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma

Outcome measures

Outcome measures
Measure	NanoPac® 6 mg/mL n=3 Participants NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 10 mg/mL n=3 Participants NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 15 mg/mL n=10 Participants NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.
Percentage of Sample Considered Adenocarcinoma Primary Tumor at Screening	53.3 percentage of sample adenocarcinoma Standard Deviation 5.8	33.3 percentage of sample adenocarcinoma Standard Deviation 24.7	47.5 percentage of sample adenocarcinoma Standard Deviation 22.0
Percentage of Sample Considered Adenocarcinoma Primary Tumor at Day 29	25.0 percentage of sample adenocarcinoma Standard Deviation 15.0	56.7 percentage of sample adenocarcinoma Standard Deviation 25.2	42.5 percentage of sample adenocarcinoma Standard Deviation 28.0

SECONDARY outcome

Timeframe: Day 1, Day 8, Day 15, Day 22, and Day 29

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	NanoPac® 6 mg/mL n=3 Participants NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 10 mg/mL n=3 Participants NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 15 mg/mL n=10 Participants NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.
Concentration of Paclitaxel in the Systemic Circulation Day 1 - 1 hr Post-Injection	5590.00 Plasma paclitaxel concentration (pg/mL) Standard Deviation 2312.336	19673.33 Plasma paclitaxel concentration (pg/mL) Standard Deviation 20736.445	19010.50 Plasma paclitaxel concentration (pg/mL) Standard Deviation 15105.857
Concentration of Paclitaxel in the Systemic Circulation Day 1 - 2 hr Post-Injection	3483.33 Plasma paclitaxel concentration (pg/mL) Standard Deviation 1851.657	9103.33 Plasma paclitaxel concentration (pg/mL) Standard Deviation 7881.982	12948.70 Plasma paclitaxel concentration (pg/mL) Standard Deviation 10230.061
Concentration of Paclitaxel in the Systemic Circulation Day 1 - 4 hr Post-Injection	2240.00 Plasma paclitaxel concentration (pg/mL) Standard Deviation 756.241	4740.00 Plasma paclitaxel concentration (pg/mL) Standard Deviation 3889.884	6830.80 Plasma paclitaxel concentration (pg/mL) Standard Deviation 5219.617
Concentration of Paclitaxel in the Systemic Circulation Day 1 - 6 hr Post-Injection	1926.67 Plasma paclitaxel concentration (pg/mL) Standard Deviation 823.549	5006.67 Plasma paclitaxel concentration (pg/mL) Standard Deviation 4938.181	5109.00 Plasma paclitaxel concentration (pg/mL) Standard Deviation 3544.025
Concentration of Paclitaxel in the Systemic Circulation Day 8	177.10 Plasma paclitaxel concentration (pg/mL) Standard Deviation 102.777	234.33 Plasma paclitaxel concentration (pg/mL) Standard Deviation 73.446	404.25 Plasma paclitaxel concentration (pg/mL) Standard Deviation 221.326
Concentration of Paclitaxel in the Systemic Circulation Day 15	65.10 Plasma paclitaxel concentration (pg/mL) Standard Deviation 24.974	82.85 Plasma paclitaxel concentration (pg/mL) Standard Deviation 7.283	106.11 Plasma paclitaxel concentration (pg/mL) Standard Deviation 62.626
Concentration of Paclitaxel in the Systemic Circulation Day 22	55.70 Plasma paclitaxel concentration (pg/mL) Standard Deviation 15.556	43.05 Plasma paclitaxel concentration (pg/mL) Standard Deviation 16.051	86.63 Plasma paclitaxel concentration (pg/mL) Standard Deviation 52.358
Concentration of Paclitaxel in the Systemic Circulation Day 29	35.45 Plasma paclitaxel concentration (pg/mL) Standard Deviation 14.496	54.75 Plasma paclitaxel concentration (pg/mL) Standard Deviation 36.275	57.64 Plasma paclitaxel concentration (pg/mL) Standard Deviation 29.269

POST_HOC outcome

Timeframe: Screening and Day 29

Population: Full Analysis Set

PSA density was measured with mpMRI

Outcome measures

Outcome measures
Measure	NanoPac® 6 mg/mL n=3 Participants NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 10 mg/mL n=3 Participants NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 15 mg/mL n=10 Participants NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.
Change in PSA Density PSA Density at Screening	3.64 ng/mL/cc Standard Deviation 5.75	0.23 ng/mL/cc Standard Deviation 0.02	0.31 ng/mL/cc Standard Deviation 0.31
Change in PSA Density PSA Density at Day 29	1.95 ng/mL/cc Standard Deviation 2.84	0.20 ng/mL/cc Standard Deviation 0.01	0.20 ng/mL/cc Standard Deviation 0.11

POST_HOC outcome

Timeframe: Screening and Day 29

Population: Full Analysis Set

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).

Outcome measures

Outcome measures
Measure	NanoPac® 6 mg/mL n=3 Participants NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 10 mg/mL n=3 Participants NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 15 mg/mL n=10 Participants NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.
Change in PI-RADS Score PI-RADS 3 : Screening	1 Participants	1 Participants	1 Participants
Change in PI-RADS Score PI-RADS 3 : Day 29	0 Participants	0 Participants	2 Participants
Change in PI-RADS Score PI-RADS 4 : Screening	0 Participants	1 Participants	5 Participants
Change in PI-RADS Score PI-RADS 4 : Day 29	1 Participants	2 Participants	2 Participants
Change in PI-RADS Score PI-RADS 5 : Screening	2 Participants	1 Participants	4 Participants
Change in PI-RADS Score PI-RADS 5 : Day 29	2 Participants	1 Participants	6 Participants

POST_HOC outcome

Timeframe: Screening and Day 29

Population: Full Analysis Set

Assessed histologically after TRUS biopsy at Screening and on Day 29 prior to prostatectomy.

Outcome measures

Outcome measures
Measure	NanoPac® 6 mg/mL n=3 Participants NanoPac® 6 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 10 mg/mL n=3 Participants NanoPac® 10 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.	NanoPac® 15 mg/mL n=10 Participants NanoPac® 15 mg/mL injected into the prostate lobe containing the dominant lesion at a volume of 20% prostate lobe volume 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.
Tumor Invasion Into Surrounding Tissues Any invasion at Day 29? No	1 Participants	1 Participants	8 Participants
Tumor Invasion Into Surrounding Tissues Any invasion at Screening? Yes	2 Participants	0 Participants	4 Participants
Tumor Invasion Into Surrounding Tissues Any invasion at Screening? No	1 Participants	3 Participants	6 Participants
Tumor Invasion Into Surrounding Tissues Any invasion at Day 29? Yes	2 Participants	2 Participants	2 Participants

Adverse Events

NanoPac® 6 mg/mL

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

NanoPac® 10 mg/mL

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

NanoPac® 15 mg/mL

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Gere S. diZerega, MD

NanOlogy, LLC

Phone: 805-595-1300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	NanoPac® 6 mg/mL n=3 participants at risk 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.	NanoPac® 10 mg/mL n=3 participants at risk 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.	NanoPac® 15 mg/mL n=10 participants at risk 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.
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Blood and lymphatic system disorders Leucocystosis	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Eye disorders Vision Blurred	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Abdominal Pain	66.7% 2/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Ileus	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	20.0% 2/10 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Procalgia	66.7% 2/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	20.0% 2/10 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
General disorders Fatigue	100.0% 3/3 • Number of events 5 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
General disorders Local swelling	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Infections and infestations Viral URTI	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	40.0% 4/10 • Number of events 4 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Injury, poisoning and procedural complications Wound complication	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Metabolism and nutrition disorders Hperglycaemia	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Nervous system disorders Headache	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	20.0% 2/10 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Nervous system disorders Lethargy	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Nervous system disorders Memory impairment	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Nervous system disorders Somnolence	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Nervous system disorders Tremor	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Renal and urinary disorders Dysuria	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Renal and urinary disorders Haematuria	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Renal and urinary disorders Micturition urgency	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Renal and urinary disorders Nocturia	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Renal and urinary disorders Pollakiuria	33.3% 1/3 • Number of events 2 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Renal and urinary disorders Urine flow decreased	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	10.0% 1/10 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Reproductive system and breast disorders Erectile dysfunction	33.3% 1/3 • Number of events 1 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/3 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.	0.00% 0/10 • 28 days, from Day 1 (the day of NanoPac injection) to Day 29 (the day of prostatectomy) Adverse events (AEs) were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.