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MRI Coil
mpMRI with Flexible AIR Coil for Prostate Cancer
N/A
Recruiting
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
Untreated, biopsy-proven with intermediate and high-risk (Gleason group grade ≥2) adenocarcinoma of the prostate
Male, Age ≥ 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial shows that mpMRI of the prostate helps accurately diagnose prostate cancer while reducing unnecessary biopsies. It's useful for active surveillance & surgical planning.
Who is the study for?
Men over 18 with intermediate to high-risk prostate cancer that hasn't been treated yet. They must be eligible for a specific type of MRI scan and considering surgery within the next 6 months. Excluded are those with certain types of prostate cancer, prior treatments, or conditions like severe hemorrhoids, recent surgeries, other active cancers in the last two years, pacemakers, or claustrophobia.Check my eligibility
What is being tested?
The study is testing how well two different MRI techniques using flexible AIR coils and endorectal coils can identify clinically significant prostate cancer. It aims to see if these methods can help avoid unnecessary biopsies by better detecting aggressive cancers needing treatment versus less serious ones that might only need monitoring.See study design
What are the potential side effects?
While not explicitly mentioned for this diagnostic trial, potential side effects may include discomfort from lying still during the MRI scan or reactions related to contrast agents used (if any), such as mild pain at injection site or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is aggressive and hasn't been treated yet.
Select...
I am a man aged 18 or older.
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
Malignant Neoplasms
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
will have an mpMRI scan with an endorectal coil
Group II: Group 1Experimental Treatment1 Intervention
will have an mpMRI scan with a flexible AIR coil.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,786,979 Total Patients Enrolled
95 Trials studying Prostate Cancer
29,482 Patients Enrolled for Prostate Cancer
Tharakeswara BathalaPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
163 Total Patients Enrolled
1 Trials studying Prostate Cancer
33 Patients Enrolled for Prostate Cancer
Tharakeswara Bathala, MBBS,MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am planning to have surgery to remove my prostate as a cure, after having an mpMRI.My prostate cancer is aggressive and hasn't been treated yet.My prostate cancer is considered low-risk.I have claustrophobia or need anesthesia for procedures.I am a man aged 18 or older.I have not had any other cancer in the last 2 years.I have received treatment for prostate cancer before.My prostate cancer has specific aggressive features.I cannot have an endorectal coil due to rectal issues.I have metal implants in my pelvis or spine.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
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.
How many participants are currently part of this research endeavor?
"Affirmative. The information posted on clinicaltrials.gov suggests that this medical research is still looking for volunteers to enroll in the trial, which was first published on July 18th 2022 and last revised on November 2nd 2022. 258 participants need to be accepted from a single site."
Answered by AI
Is there still an opportunity to participate in this research endeavor?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial, which was launched on July 18th 2022, is actively recruiting participants. 258 individuals are sought after to take part in the experiment at 1 particular site."
Answered by AI
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