Prostate Adenocarcinoma, Prostate Carcinoma
Conditions
Brief summary
This clinical trial studies examines a 3D magnetic resonance imaging (MRI) compared to standard MRI imaging techniques in screening patients with prostate cancer. Diagnostic procedures, such as MRI, may help find and diagnose prostate cancer. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning.
Detailed description
PRIMARY OBJECTIVE: I. To determine whether the image quality of the novel 3-dimensional (3D) T2-weighted imaging (T2W) synthetic imaging technique without endorectal coil is comparable to the 2-dimensional (2D) T2W imaging technique without endorectal coil. SECONDARY OBJECTIVE: I. To evaluate the qualitative diagnostic quality of the T2W images provided by the novel 3D technique, as determined by subjective scoring by experienced readers. EXPLORATORY OBJECTIVE: I. To investigate the feasibility of novel 3D synthetic imaging and multi-spin parameter mapping technique of prostate for the detection of clinically significant prostate cancer (csPCa). OUTLINE: Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.
Interventions
PROCEDUREMagnetic Resonance Imaging
Undergo 3D MRI
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male, age \>= 18 * Untreated, biopsy-proven with intermediate and high-risk adenocarcinoma of the prostate * Patient is being considered for curative-intent treatment with radical prostatectomy * Patient has provided written informed consent for participation in this trial * Patient should be eligible for scanning on a 3T magnet
Exclusion criteria
* Low-risk adenocarcinoma of prostate * Any prior therapy for prostate cancer * A history of other active malignancy within the last 2 years * Prostate cancer with significant sarcomatoid, spindle cell, or neuroendocrine small cell components * Cardiac pacemaker * Orthopedic hardware in the pelvis and spine * Claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue | through study completion, an average of 1 year | Comparing the 2-dimensional (2D) T2W imaging technique without endorectal coil. Scored from 1 to 5 with PI-RADS 1 indicating that csPCa is highly unlikely whereas a PI-RADS 5 score indicates that csPCa is highly likely to be present. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTharakeswara Bathala
M.D. Anderson Cancer Center
Outcome results
None listed