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Imaging Technique
Advanced MRI Techniques for Prostate Cancer
N/A
Waitlist Available
Led By Tharakeswara Bathala
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial looks at whether 3D MRI is better than standard MRI in finding prostate cancer.
Who is the study for?
This trial is for men aged 18 or older with intermediate to high-risk prostate cancer that hasn't been treated yet. They must be considering a radical prostatectomy (surgery to remove the prostate) and able to undergo scanning with a 3T magnet MRI. Exclusions include having a pacemaker, metal in the pelvis/spine, active cancers within 2 years, claustrophobia, low-risk cancer types or specific cellular features.Check my eligibility
What is being tested?
The study is testing how well a new type of 3D MRI technique works compared to standard MRI methods in screening patients with prostate cancer. The goal is to see if this new imaging can create better three-dimensional pictures of tumors which may improve diagnosis and treatment planning.See study design
What are the potential side effects?
Since the intervention involves only MRI imaging, there are no direct side effects like those from medications; however, individuals might experience discomfort from lying still during the scan or anxiety due to being in an enclosed space.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To be assessed with scoring of quantitative image metrics in regions of prostate cancer and benign tissue
Side effects data
From 2022 Phase 3 trial • 53 Patients • NCT0003329319%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
11600-Alanine aminotransferase increased
8%
16800-Bladder infection
8%
44800-Infections and infestations - Other specify
8%
58700-Nystagmus
4%
15000-Aspartate aminotransferase increased
4%
88500-White blood cell decreased
4%
15300-Ataxia
4%
33900-Fever
4%
25700-Diarrhea
4%
43100-Hypokalemia
4%
69700-Rash maculo-papular(targeted toxicity)
4%
13200-Anemia
4%
33300-Febrile neutropenia
4%
57600-Nausea(targeted toxicity)
4%
20500-Catheter related infection
4%
58300-Neutrophil count decreased
4%
41300-Hypercalcemia
4%
41400-Hyperglycemia(targeted toxicity)
4%
41600-Hyperkalemia
4%
42600-Hypoalbuminemia
4%
42700-Hypocalcemia
4%
64400-Personality change
4%
41500-Hyperhidrosis
4%
13500-Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Screening (3D MRI)Experimental Treatment1 Intervention
Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,769 Total Patients Enrolled
95 Trials studying Prostate Cancer
29,707 Patients Enrolled for Prostate Cancer
Tharakeswara BathalaPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
388 Total Patients Enrolled
1 Trials studying Prostate Cancer
258 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a pacemaker for your heart.You have metal implants in your spine or pelvis.You are being considered for a surgery called radical prostatectomy to treat your prostate cancer with the goal of curing it.You had another type of cancer within the past two years that is still active.You are afraid of small spaces.You are able to undergo imaging scans on a 3T magnet.You have received treatment for prostate cancer in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Screening (3D MRI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide an estimate of how many individuals are currently involved in this clinical investigation?
"Affirmative. Clinicaltrials.gov highlights that this clinical trial is currently recruiting participants, having been first listed on August 10th 2021 and last edited on August 18th 2022. This study requires 20 patients to be recruited from one medical site."
Answered by AI
Does this investigation have availability for participants?
"Affirmative. According to information on clinicaltrials.gov, this medical trial is currently enrolling subjects. The study was initially posted on August 10th 2021 and its last update came out August 18th 2022, with a goal of recruiting 20 patients from 1 site."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
M D Anderson Cancer Center
How many prior treatments have patients received?
0
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