Your session is about to expire
← Back to Search
Diagnostic Test
PSMA-PET + MRI for Prostate Cancer
Phase 2 & 3
Recruiting
Led By Clinton Bahler, MD
Research Sponsored by Five Eleven Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% OR ≥3 cores of Gleason 3+4 OR Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5
Men diagnosed with prostate cancer who choose radical prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial will test whether adding a PSMA PET scan to the standard of care MRI scan before surgery helps doctors better understand the cancer and leads to better patient outcomes.
Who is the study for?
Men with significant prostate cancer planning to undergo surgery can join. They should have a certain level of prostate cancer severity, based on Gleason scores, and wish to maintain erections post-treatment. Men with any serious health issues, participating in other radiation trials recently, or unable to stay still for imaging due to physical limits or claustrophobia cannot participate.Check my eligibility
What is being tested?
The trial is testing if adding a PSMA-PET scan alongside the standard MRI before surgery provides better information than just the MRI alone. The study will see if this extra scan changes surgical plans and improves outcomes by comparing two groups: one gets only an MRI and the other gets both an MRI and PSMA-PET.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medications, side effects are minimal but may include discomfort from lying still during scans and potential anxiety related to claustrophobia in imaging devices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is aggressive based on my biopsy results.
Select...
I am a man with prostate cancer opting for surgery to remove my prostate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
IIEF-EF sub scale score
Secondary outcome measures
Therapeutic procedure
EPE detection
Erectile dysfunction: ability to achieve erection sufficient for penetration
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PSMA-PET and SOC MRI prior to surgeryExperimental Treatment1 Intervention
Group II: SOC MRI prior to surgeryActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Five Eleven Pharma, Inc.Lead Sponsor
5 Previous Clinical Trials
122 Total Patients Enrolled
3 Trials studying Prostate Cancer
104 Patients Enrolled for Prostate Cancer
Indiana UniversityOTHER
980 Previous Clinical Trials
982,988 Total Patients Enrolled
7 Trials studying Prostate Cancer
397 Patients Enrolled for Prostate Cancer
Clinton Bahler, MDPrincipal InvestigatorIndiana University School of Medicine
1 Previous Clinical Trials
36 Total Patients Enrolled
1 Trials studying Prostate Cancer
36 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I want to keep my ability to have erections after treatment.I cannot stay still on a PET or MRI machine due to physical issues or claustrophobia.My prostate cancer is aggressive based on my biopsy results.I do not have any major health issues that could interfere with the study.I am a man with prostate cancer opting for surgery to remove my prostate.
Research Study Groups:
This trial has the following groups:- Group 1: PSMA-PET and SOC MRI prior to surgery
- Group 2: SOC MRI prior to surgery
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.
Can I join the trial if I am interested?
"Yes, this trial is still recruiting patients according to the latest information available from clinicaltrials.gov. The listing for this study was first posted on March 1st, 2022 and was last updated on May 15th, 2022."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger