PSMA-PET and SOC MRI for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate CancerPSMA-PET and SOC MRI - DiagnosticTest
Eligibility
Any Age
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 18 months

1 month
Therapeutic procedure
EPE detection
Ratio of positive surgical margins to nerve bundles spared
Surgical margins
18 months
Erectile dysfunction: ability to achieve erection sufficient for penetration
IIEF-EF sub scale score
Incontinence bother
Incontinence: using 0-1 pads per day
Overall mental and physical health
Urgency/frequency

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

SOC MRI prior to surgery
1 of 2
PSMA-PET and SOC MRI prior to surgery
1 of 2

Active Control

Experimental Treatment

288 Total Participants · 2 Treatment Groups

Primary Treatment: PSMA-PET and SOC MRI · No Placebo Group · Phase 2 & 3

PSMA-PET and SOC MRI prior to surgery
DiagnosticTest
Experimental Group · 1 Intervention: PSMA-PET and SOC MRI · Intervention Types: DiagnosticTest
SOC MRI prior to surgery
DiagnosticTest
ActiveComparator Group · 1 Intervention: SOC MRI · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

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
876 Previous Clinical Trials
749,288 Total Patients Enrolled
6 Trials studying Prostate Cancer
297 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

Eligibility Criteria

Age Any Age · Male Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no erectile dysfunction, mild erectile dysfunction, or mild-to-moderate erectile dysfunction.