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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

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ClinicalTrials.gov Identifier: NCT01174368
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Biological: Cancer Macrobead placement in abdominal cavity
Enrollment 1

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cancer Macrobeads
Hide Arm/Group Description

Cancer Macrobead placement in abdominal cavity

Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Cancer Macrobeads
Hide Arm/Group Description

Cancer Macrobead placement in abdominal cavity

Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
No analysis was performed due to small sample size. The one baseline participant withdrew voluntarily from the study after first implantation.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
1
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 1 participants
1
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title Overall Survival
Hide Description Data was not collected.
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected.
Arm/Group Title Cancer Macrobeads
Hide Arm/Group Description:

Cancer Macrobead placement in abdominal cavity

Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Metastases
Hide Description [Not Specified]
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected. No statistical analysis was performed due to the sample size of one patient.
Arm/Group Title Cancer Macrobeads
Hide Arm/Group Description:

Cancer Macrobead placement in abdominal cavity

Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression-free Survival
Hide Description No data was collected.
Time Frame 16 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected.
Arm/Group Title Cancer Macrobeads
Hide Arm/Group Description:

Cancer Macrobead placement in abdominal cavity

Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cancer Macrobeads
Hide Arm/Group Description

Cancer Macrobead placement in abdominal cavity

Cancer Macrobead placement in abdominal cavity: 8 macrobeads per kilogram

All-Cause Mortality
Cancer Macrobeads
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cancer Macrobeads
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cancer Macrobeads
Affected / at Risk (%)
Total   1/1 (100.00%) 
General disorders   
Fatigue  1/1 (100.00%) 
Fever  1/1 (100.00%) 
Decreased appetite  1/1 (100.00%) 
Diaphoresis   1/1 (100.00%) 
Urinary urgency  1/1 (100.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Angelica Nazarian
Organization: The Rogosin Institute
Phone: 212-746-1551
Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01174368     History of Changes
Other Study ID Numbers: 1003010955
First Submitted: August 1, 2010
First Posted: August 3, 2010
Results First Submitted: May 29, 2018
Results First Posted: October 17, 2018
Last Update Posted: October 17, 2018