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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after the 68ga psma pet scan
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 and 12 months after 68ga psma pet scan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 12 months after 68ga psma pet scan
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSide effects data
From 2021 Phase 2 & 3 trial • 22 Patients • NCT033883465%
Surgical and medical procedures - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
68Ga PSMA PET Scan
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
62 Total Patients Enrolled
2 Trials studying Prostate Cancer
62 Patients Enrolled for Prostate Cancer
Michael M Graham, Ph.D., MDStudy ChairUniversity of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not taking any experimental drugs that have not been approved by regulatory agencies for testing their effectiveness.I can understand and agree to participate in the study.You are allergic to medications that contain sulfa.My PSA levels are increasing after having surgery or radiation for prostate cancer.I have been diagnosed with prostate cancer.I have no other cancer besides the one currently being studied.You have had Stevens-Johnson syndrome in the past.I do not have any serious illnesses that would stop me from following the study's requirements.I've been mostly active and able to care for myself in the last 3 months.I haven't had any cancer except for certain skin or superficial bladder cancers in the last 2 years.My PSA levels have risen by 2 mg/mL or more after radiation therapy.I cannot take furosemide.After prostate surgery, my PSA levels have been above 0.2 ng/mL twice.I have been diagnosed with or have a history of Paget's disease.
Research Study Groups:
This trial has the following groups:- Group 1: 68Ga PSMA PET scan
Awards:
This trial has 2 awards, including:- 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.
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.
Before this study, was there any other research conducted on Ga-68 PSMA-HBED-CC PET?
"There are 8 clinical trials underway to study Ga-68 PSMA-HBED-CC PET. Of these active trials, 2 have progressed to Phase 3. Most of the research taking place for Ga-68 PSMA-HBED-CC PET is based in Iowa City, Iowa, but there are 8 total locations running these studies."
Answered by AI
What is the total amount of people that are participating in this clinical trial?
"Unfortunately, this particular study has already closed recruitment. Although, there are 4576 other trials concerning prostatic cancer, castration-resistant that are still enrolling participants. Additionally, there are 8 other Ga-68 PSMA-HBED-CC PET trials that remain open."
Answered by AI
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