Prostate Cancer
Conditions
Keywords
Prostate Cancer, Dynamic Contrast Enhanced MRI, Non-invasive Prostate Cancer Detection
Brief summary
The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project. Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.
Detailed description
Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging. Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.
Interventions
DEVICEMRI 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.
Sponsors
Midwest Stone Institute.
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients who have been diagnosed with prostate cancer and are scheduled for radical prostatectomy or for brachytherapy * patients who have not received any preoperative treatment for their diagnosis of prostate cancer
Exclusion criteria
* patients with implants that are electronically, magnetically, or mechanically active * patients with intracranial aneurysm clips * patients who have undergone cosmetic eyelid surgery * patients with history of pheochromocytoma, insulinoma and acute glaucoma * patients with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved Accuracy of Prostate Cancer Detection by MRI Scan. | At time of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients. | At time of treatment | Ultrasound guidance of transrectal ultrasound biopsy was not attempted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 5 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | screen failure | 5 | 0 |
Baseline characteristics
| Characteristic | Brachytherapy Patients | Radical Prostatectomy Patients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 19 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 41 Participants | 43 Participants |
| Age, Continuous | 66 years | 60 years | 61 years |
| Region of Enrollment United States | 5 participants | 60 participants | 65 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 60 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 5 |
| serious Total, serious adverse events | 0 / 60 | 0 / 5 |
Outcome results
Primary
Improved Accuracy of Prostate Cancer Detection by MRI Scan.
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.
Time frame: At time of treatment
Population: 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.
Secondary
Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.
Ultrasound guidance of transrectal ultrasound biopsy was not attempted.
Time frame: At time of treatment
Population: 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.