Trial Outcomes & Findings for Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy (NCT NCT01804712)
NCT ID: NCT01804712
Last Updated: 2026-03-12
Results Overview
Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm\^2/mm\^2)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
1 treatment cycle (28 days)
Results posted on
2026-03-12
Participant Flow
Participant milestones
| Measure |
Rituximab
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Rituximab
n=8 Participants
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
|
|---|---|
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Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 5.2 • n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
PSA at dx
|
7.7 ng/mL
STANDARD_DEVIATION 4.7 • n=9 Participants
|
PRIMARY outcome
Timeframe: 1 treatment cycle (28 days)Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm\^2/mm\^2)
Outcome measures
| Measure |
Rituximab
n=8 Participants
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
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|---|---|
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B-cell Density Stained Area
|
0.027 mm^2/mm^2
Interval 0.021 to 0.033
|
SECONDARY outcome
Timeframe: from Day 1 to Day 29Prostate-specific antigen (PSA)
Outcome measures
| Measure |
Rituximab
n=8 Participants
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
|
|---|---|
|
Prostate-specific Antigen (PSA)
Day 1
|
8.1 ng/mL
Interval 4.26 to 11.94
|
|
Prostate-specific Antigen (PSA)
Day 29
|
8.36 ng/mL
Interval 4.0 to 12.72
|
SECONDARY outcome
Timeframe: from Day 1 to Day 29Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm\^2/mm\^2)
Outcome measures
| Measure |
Rituximab
n=8 Participants
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
|
|---|---|
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Change in Tumor B-cell Stained Area
|
-0.005 mm^2/mm^2
Interval -0.028 to 0.017
|
SECONDARY outcome
Timeframe: from Day 1 to Day 29Immunohistochemical staining of serial prostatectomy sections to measure the density of CD3+ T-cells as stained area (mm\^2/mm\^2)
Outcome measures
| Measure |
Rituximab
n=8 Participants
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
|
|---|---|
|
Tumor CD3+ T-cell Stained Area
|
0.022 mm^2/mm^2
Interval 0.012 to 0.033
|
Adverse Events
Rituximab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=8 participants at risk
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
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|---|---|
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Vascular disorders
Grade 4 thromboembolic event
|
12.5%
1/8 • Number of events 1 • 56 days
|
Other adverse events
| Measure |
Rituximab
n=8 participants at risk
Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
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|---|---|
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General disorders
|
50.0%
4/8 • Number of events 9 • 56 days
|
Additional Information
Dr. Christopher Kane
University of California, San Diego
Phone: (858) 822-5354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place