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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
No Placebo-Only Group
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 18 months of rt completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 18 months of rt completion
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.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,174 Previous Clinical Trials
1,572,840 Total Patients Enrolled
7 Trials studying Prostate Cancer
1,670 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer, but it's either in remission or won't affect my prostate cancer treatment.I have had treatments like cryotherapy or surgery for prostate cancer.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.I am scheduled for radiotherapy with hormone therapy before and during treatment.I have had radiation therapy to my pelvic area before.I am a man over 18 with confirmed prostate cancer.I plan to follow standard care for my prostate cancer treatment.I am in good health and can take care of myself.
Research Study Groups:
This trial has the following groups:- Group 1: RSI-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.
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