Trial Outcomes & Findings for Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer (NCT NCT03964337)
NCT ID: NCT03964337
Last Updated: 2022-06-29
Results Overview
Apoptotic index as measured by cleaved caspase-3 levels in tumor tissue
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
At prostatectomy (Arm A: Day 43, Arm B: Day 1)
Results posted on
2022-06-29
Participant Flow
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B).
Participant milestones
| Measure |
Cabozantinib Followed by Prostatectomy (Arm A)
Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.
Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.
Radical Prostatectomy: Radical prostatectomy as part of routine medical care.
|
Immediate Prostatectomy (Arm B)
Control group will receive an immediate prostatectomy.
Radical Prostatectomy: Radical prostatectomy as part of routine medical care.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Cabozantinib Followed by Prostatectomy (Arm A)
n=3 Participants
Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.
Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.
Radical Prostatectomy: Radical prostatectomy as part of routine medical care.
|
Immediate Prostatectomy (Arm B)
Control group will receive an immediate prostatectomy.
Radical Prostatectomy: Radical prostatectomy as part of routine medical care.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.47 years
STANDARD_DEVIATION 8.40 • n=5 Participants
|
—
|
62.47 years
STANDARD_DEVIATION 8.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Apoptotic index as measured by cleaved caspase-3 levels in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1Population: Data not collected.
Percentage of MDSCs in peripheral blood and tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1Population: Data not collected.
Percentage of neutrophils in peripheral blood and tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1Population: Data not collected.
Percentage of M1 macrophages in peripheral blood and tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Arm A: Screening, Day 29, Day 43, Day 57-85; Arm B: Screening, Day 1Population: Data not collected.
Percentage of M2 macrophages in peripheral blood and tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of CD8+ positive cells in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of PD-L1 positive cells in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of CTLA-4 positive cells in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of IL-1RA positive cells in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of neutrophil chemotactic factor CXCL12 positive cells in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of neutrophil chemotactic factor HMGB1 positive cells in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of MDSC-promoting cytokine CCL5 positive cells in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of MDSC-promoting cytokine CCL12 positive cells in tumor tissue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At prostatectomy (Arm A: Day 43, Arm B: Day 1)Population: Data not collected.
Percentage of MDSC-promoting cytokine CD40 cells in tumor tissue
Outcome measures
Outcome data not reported
Adverse Events
Cabozantinib Followed by Prostatectomy (Arm A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Immediate Prostatectomy (Arm B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cabozantinib Followed by Prostatectomy (Arm A)
n=3 participants at risk
Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.
Cabozantinib: Cabozantinib 40 mg by mouth daily for 4 weeks.
Radical Prostatectomy: Radical prostatectomy as part of routine medical care.
|
Immediate Prostatectomy (Arm B)
Control group will receive an immediate prostatectomy.
Radical Prostatectomy: Radical prostatectomy as part of routine medical care.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
General disorders
Pain
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Investigations
Investigations - Other
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Renal and urinary disorders
Bladder spasm
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Renal and urinary disorders
Urinary incontinence
|
66.7%
2/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
66.7%
2/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
—
0/0 • Per the protocol, AEs are collected from the first dose of study drug (Day 0) through 30 days after the decision to discontinue study treatment (Day 57).
Study accrual was discontinued prior to enrolling any participants in the control arm (Immediate Prostatectomy, Arm B). AEs were predominantly collected at protocol required study visits. The study coordinator would ask the subject about their health and any side effects they experienced. The investigator would perform a physical exam. Blood was collected for safety labs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place