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Radiopharmaceutical

68Ga PSMA-11 injection for Prostate Cancer

Phase 2
Waitlist Available
Led By Neil Rofsky, MD, MHA
Research Sponsored by Dana Mathews
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during mpmri, up to 2 hours
Awards & highlights

Study Summary

This trial is testing whether a new kind of PET scan can help doctors better locate prostate cancer lesions.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during mpmri, up to 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and during mpmri, up to 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Primary Prostate Lesions Detected by mpMRI
Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging
Secondary outcome measures
Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)
Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with suspected prostate cancerExperimental Treatment2 Interventions
Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
68Ga PSMA-11 injection
2020
Completed Phase 2
~20
Positron Emission Tomography/Computed Tomography
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Dana MathewsLead Sponsor
2 Previous Clinical Trials
2 Trials studying Prostate Cancer
Neil Rofsky, MD, MHAPrincipal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
2 Trials studying Prostate Cancer
Orhan K Oz, MD, PhDPrincipal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
2 Trials studying Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research still enrolling participants?

"Clinicaltrials.gov data indicates that this research project is currently enrolling participants, having been initially posted on 27th January 2020 and most recently updated 21st January 2022."

Answered by AI

What is the enrollment capacity for this research trial?

"Affirmative. Clinicaltrials.gov data indicates that this investigation, which was initially displayed on January 27th 2020, is actively looking for participants. A total of 20 people are required to be recruited from a single medical site."

Answered by AI

What potential risks can be associated with 68Ga PSMA-11 injection?

"Considering the fact that 68Ga PSMA-11 injection is only at Phase 2 and there is limited data in support of its efficacy, we have assigned it a safety rating of 2."

Answered by AI
~4 spots leftby Mar 2025