Trial Outcomes & Findings for Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma (NCT NCT00851682)
NCT ID: NCT00851682
Last Updated: 2018-10-31
Results Overview
Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.
TERMINATED
NA
65 participants
At time of treatment
2018-10-31
Participant Flow
Participant milestones
| Measure |
Radical Prostatectomy Patients
Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.
|
Brachytherapy Patients
Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
5
|
|
Overall Study
COMPLETED
|
55
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Radical Prostatectomy Patients
Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.
|
Brachytherapy Patients
Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.
|
|---|---|---|
|
Overall Study
screen failure
|
5
|
0
|
Baseline Characteristics
Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
Baseline characteristics by cohort
| Measure |
Radical Prostatectomy Patients
n=60 Participants
Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.
|
Brachytherapy Patients
n=5 Participants
Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Age, Continuous
|
60 years
n=93 Participants
|
66 years
n=4 Participants
|
61 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=93 Participants
|
5 participants
n=4 Participants
|
65 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: At time of treatmentPopulation: Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.
Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of treatmentPopulation: Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.
Ultrasound guidance of transrectal ultrasound biopsy was not attempted.
Outcome measures
Outcome data not reported
Adverse Events
Radical Prostatectomy Patients
Brachytherapy Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place