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[68Ga]P15-041 for Prostate Cancer

Phase < 1
Waitlist Available
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
histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical [99mTc]MDP scan
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes post injection
Awards & highlights

Study Summary

This trial will test if a new imaging agent can help doctors better visualize and target prostate cancer that has spread to the bone.

Eligible Conditions
  • Prostate Cancer
  • Bone Metastases

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes post injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time course of uptake of [68Ga]P15-041 in bone metastases
Time course of whole body distribution of [68Ga]P15-041

Trial Design

2Treatment groups
Experimental Treatment
Group I: Whole body dosimetry groupExperimental Treatment1 Intervention
Determination of human dosimetry of the investigation drug [68Ga]P15-041
Group II: Dynamic imaging groupExperimental Treatment1 Intervention
Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[68Ga]P15-041
2016
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

Five Eleven Pharma, Inc.Lead Sponsor
5 Previous Clinical Trials
396 Total Patients Enrolled
3 Trials studying Prostate Cancer
378 Patients Enrolled for Prostate Cancer
~2 spots leftby May 2025
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