Trial Outcomes & Findings for Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-T (NCT NCT01174368)

Results Overview

Data was not collected.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

16 months

Results posted on

2019-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Cancer Macrobeads Cancer Macrobead placement in abdominal cavity Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cancer Macrobeads Cancer Macrobead placement in abdominal cavity Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-T

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cancer Macrobeads n=1 Participants Cancer Macrobead placement in abdominal cavity Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	1 participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 months

Population: Data was not collected.

Data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months

Population: Data was not collected. No statistical analysis was performed due to the sample size of one patient.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months

Population: Data was not collected.

No data was collected.

Outcome measures

Outcome data not reported

Adverse Events

Cancer Macrobeads

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cancer Macrobeads n=1 participants at risk Cancer Macrobead placement in abdominal cavity Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram
General disorders Fatigue	100.0% 1/1
General disorders Fever	100.0% 1/1
General disorders Decreased appetite	100.0% 1/1
General disorders Diaphoresis	100.0% 1/1
General disorders Urinary urgency	100.0% 1/1

Additional Information

Angelica Nazarian

The Rogosin Institute

Phone: 212-746-1551

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place