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Ga-68 PSMA PET/CT for Prostate Cancer

Phase 2 & 3
Waitlist Available
Research Sponsored by Michael Graham PhD, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).
Pathologically proven prostate adenocarcinoma.
Must not have
Malignancy other than current disease under study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after the 68ga psma pet scan
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is investigating if a new drug, PSMA, can be used to more easily identify prostate cancer in PET scans. If successful, this could allow for more targeted and effective treatments for prostate cancer.

Who is the study for?
This trial is for men with prostate cancer that has returned after surgery or radiation therapy. They must have a specific level of PSA, a protein linked to prostate cancer, in their blood and be generally healthy without other recent cancers (except certain skin or superficial bladder cancers). Participants can't join if they're taking experimental drugs, allergic to sulfa medications, have heart problems, uncontrolled illnesses, or conditions affecting study compliance.
What is being tested?
The trial tests whether injecting Ga-68 PSMA before PET/CT imaging helps better detect where the prostate cancer is located. This could lead to more targeted treatments. The drug contains a small amount of radioactive material but within safe exposure limits for patients.
What are the potential side effects?
Potential side effects from the Ga-68 PSMA injection are not detailed here but may include reactions related to the radiolabeled substance used for imaging purposes. Side effects might also arise from the PET/CT procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My PSA levels are increasing after having surgery or radiation for prostate cancer.
Select...
I have been diagnosed with prostate cancer.
Select...
My PSA levels have risen by 2 mg/mL or more after radiation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no other cancer besides the one currently being studied.
Select...
I do not have any serious illnesses that would stop me from following the study's requirements.
Select...
I cannot take furosemide.
Select...
I have been diagnosed with or have a history of Paget's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 12 months after 68ga psma pet scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 12 months after 68ga psma pet scan for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine sensitivity on a per-patient basis of 68Ga PSMA PET scans for detection of tumor location [CT.gov: ref: NCT03389451 for all comments]
Determine sensitivity on a per-region basis of 68Ga PSMA PET scans for detection of tumor location
Secondary study objectives
Determine detection rates on a per-subject basis of 68Ga PSMA-HBED-CC PET/CT when stratified by PSA value
Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location
Determine sensitivity on per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology.
+1 more

Side effects data

From 2021 Phase 2 & 3 trial • 22 Patients • NCT03388346
5%
Surgical and medical procedures - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
68Ga PSMA PET Scan

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: 68Ga PSMA PET scanExperimental Treatment1 Intervention
Ga-68 PSMA-HBED-CC PET/CT scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium-68 PSMA
FDA approved

Find a Location

Who is running the clinical trial?

Michael Graham PhD, MDLead Sponsor
2 Previous Clinical Trials
52 Total Patients Enrolled
2 Trials studying Prostate Cancer
52 Patients Enrolled for Prostate Cancer
Michael M Graham, Ph.D., MDStudy ChairUniversity of Iowa

Media Library

Ga-68 PSMA-HBED-CC PET Clinical Trial Eligibility Overview. Trial Name: NCT03822845 — Phase 2 & 3
Prostate Cancer Research Study Groups: 68Ga PSMA PET scan
Prostate Cancer Clinical Trial 2023: Ga-68 PSMA-HBED-CC PET Highlights & Side Effects. Trial Name: NCT03822845 — Phase 2 & 3
Ga-68 PSMA-HBED-CC PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT03822845 — Phase 2 & 3
~36 spots leftby Dec 2025
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