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Diagnostic Test
Biparametric MRI Screening for Prostate Cancer
N/A
Recruiting
Led By Ardeshir Rastinehad, DO
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will test whether using MRI to screen for prostate cancer in addition to the PSA test will improve the accuracy of prostate cancer screening.
Who is the study for?
This trial is for men at high risk of prostate cancer, which includes Black men or those with a family history (father, brother) or specific genetic mutations (BRCA 1/2, HOX B13). Participants should have PSA levels between 1.0 and 2.5 ng/dL and be able to consent. Men who've had recent UTIs, prostatitis, prostate surgery/biopsy, take certain medications for enlarged prostate, or can't undergo MRI are excluded.Check my eligibility
What is being tested?
The study tests if biparametric MRI as a screening tool alongside PSA testing improves detection of prostate cancer in high-risk individuals. It aims to see whether this method can better identify patients who may need further investigation compared to current screening protocols.See study design
What are the potential side effects?
While the biparametric MRI itself doesn't involve medication and thus has no direct side effects like drugs do, participants might experience discomfort from lying still during the scan or anxiety due to claustrophobia inside the scanner.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml
Secondary outcome measures
Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.
Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI
To correlate bpMRI findings with future changes in PSA
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bi-parametric Screening MRIExperimental Treatment1 Intervention
Bi-parametric MRI to be administered to High Risk males
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,833 Total Patients Enrolled
4 Trials studying Prostate Cancer
566 Patients Enrolled for Prostate Cancer
Ardeshir Rastinehad, DOPrincipal InvestigatorNorthwell Health
3 Previous Clinical Trials
2,306 Total Patients Enrolled
2 Trials studying Prostate Cancer
1,786 Patients Enrolled for Prostate Cancer
Manish Vira, MDPrincipal InvestigatorNorthwell Health
1 Previous Clinical Trials
107 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and agree to the study's procedures and risks.I feel claustrophobic, anxious, or dizzy in tight spaces like a scanner.I cannot lie flat for long periods.I have had a urinary tract infection or prostate inflammation in the last 6 months.I am taking medication for an enlarged prostate, which affects my PSA levels.I have had a biopsy or surgery on my prostate before.I am at high risk for prostate cancer due to my race, family history, or specific genetic conditions.My prostate feels lumpy or firm when examined.
Research Study Groups:
This trial has the following groups:- Group 1: Bi-parametric Screening 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.
Are there any patients being recruited for this research project at the moment?
"According to the information available on clinicaltrials.gov, this trial is still recruiting patients. This study was originally posted on 8/15/2022 and was last updated on 8/26/2022. They are currently looking for 100 individuals to participate at 1 location."
Answered by AI
Does the upper age limit for this experiment extend to octogenarians?
"The study is looking for patients aged between 40-55."
Answered by AI
How many total patients are enrolled in this clinical trial?
"That is correct. Based on the information available on clinicaltrials.gov, this study is still actively looking for participants. The posting date was 8/15/2022 and the most recent update was on 8/26/2022. They are currently recruiting for 100 participants from 1 site."
Answered by AI
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