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MRI

RSI MRI Monitoring for Prostate Cancer (ProsRSI Trial)

Phase 2
Recruiting
Led By Tyler Seibert, MD, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
High-risk prostate cancer (PSA ≥20 ng/mL or cT3-T4 stage or Gleason score ≥8)
Planning to undergo definitive radiotherapy with neoadjuvant and concurrent androgen deprivation therapy
Must not have
Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy)
Prior radiotherapy to the pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 18 months of rt completion
Awards & highlights

Summary

This trial will test whether an MRI can predict how well a patient will respond to radiation therapy and androgen deprivation therapy for high-risk, localized prostate cancer.

Who is the study for?
This trial is for adult males with high-risk, localized prostate cancer who are planning to undergo radiation and hormone therapy. They must be in good health overall, have a specific level of disease severity (PSA ≥20 ng/mL or advanced stage), and agree to follow the study procedures. Men with other cancers, previous prostate treatments, or conditions that interfere with MRI scans cannot participate.
What is being tested?
The ProsRSI trial is testing an advanced MRI technique called Restriction Spectrum Imaging (RSI-MRI) on patients undergoing standard treatment for high-risk prostate cancer. The goal is to see if RSI-MRI can predict how well the treatment works.
What are the potential side effects?
Since this trial involves only additional imaging without any new drugs or invasive procedures, side effects are minimal but may include discomfort during the MRI scan and anxiety related to being in a confined space.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is high-risk with a PSA over 20, or it's in an advanced stage, or my Gleason score is 8 or higher.
Select...
I am scheduled for radiotherapy with hormone therapy before and during treatment.
Select...
I am a man over 18 with confirmed prostate cancer.
Select...
I am in good health and can take care of myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had treatments like cryotherapy or surgery for prostate cancer.
Select...
I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 18 months of rt completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 18 months of rt completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biochemical recurrence (PSA 2 ng/mL greater than nadir) within 3 years of completing RT.
Secondary study objectives
PSA nadir within the 18 months after RT ≥0.5 ng/mL.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RSI-MRIExperimental Treatment1 Intervention
Participants will undergo RSI-MRI at three time points: before androgen deprivation therapy (ADT); after neoadjuvant ADT but before radiation therapy (RT); and after RT.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,157 Previous Clinical Trials
1,571,319 Total Patients Enrolled
8 Trials studying Prostate Cancer
4,670 Patients Enrolled for Prostate Cancer
Tyler Seibert, MD, PhDPrincipal Investigator - University of California, San Diego
University of California, San Diego
2 Previous Clinical Trials
600 Total Patients Enrolled
2 Trials studying Prostate Cancer
600 Patients Enrolled for Prostate Cancer

Media Library

Restriction Spectrum Imaging Magnetic Resonance Imaging (MRI) Clinical Trial Eligibility Overview. Trial Name: NCT04349501 — Phase 2
Prostate Cancer Research Study Groups: RSI-MRI
Prostate Cancer Clinical Trial 2023: Restriction Spectrum Imaging Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT04349501 — Phase 2
Restriction Spectrum Imaging Magnetic Resonance Imaging (MRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04349501 — Phase 2
~4 spots leftby Dec 2024
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