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PSMA PET Imaging for Prostate Cancer
Phase 2
Waitlist Available
Led By Heiko Schöder, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Biopsy proven adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new imaging agent to see if it can better detect prostate cancer, especially when PSA levels are low.
Who is the study for?
This trial is for men over 18 with biopsy-proven prostate adenocarcinoma, whose PSA levels have risen by at least 2 ng/ml after initial treatments like surgery or radiation. They must be able to undergo PET/CT scans and not have claustrophobia or other issues that would make such imaging difficult.Check my eligibility
What is being tested?
The study tests a new diagnostic agent called 68Ga-HBED-CC-PSMA in detecting recurrent prostate cancer on PET/CT scans, especially when PSA levels are low but rising, indicating potential cancer activity.See study design
What are the potential side effects?
While the document doesn't list specific side effects, generally PET/CT imaging may cause discomfort due to lying still for long periods and anxiety in some patients. The injected tracer can sometimes cause mild allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My prostate cancer was confirmed by a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease localization by PSMA PET/MR
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)
PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT
Trial Design
2Treatment groups
Active Control
Group I: Ga-HBED-iPSMA PET with CT or MRIActive Control3 Interventions
Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
Group II: Ga-HBED-iPSMA PET with MRIActive Control2 Interventions
Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
584,033 Total Patients Enrolled
132 Trials studying Prostate Cancer
50,903 Patients Enrolled for Prostate Cancer
Heiko Schöder, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
119 Total Patients Enrolled
1 Trials studying Prostate Cancer
20 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to be able to undergo a PET/CT or PET/MR scan without any problems.I had surgery or radiation (or both) as my first cancer treatment.I was first treated with surgery or specific types of therapy for my condition.My prostate cancer was confirmed by a biopsy.I am 18 years old or older.I have had treatment for cancer that came back or spread.
Research Study Groups:
This trial has the following groups:- Group 1: Ga-HBED-iPSMA PET with CT or MRI
- Group 2: Ga-HBED-iPSMA PET with MRI
Awards:
This trial has 1 awards, including:- 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.
Does the FDA sanction Ga-HBED-iPSMA PET with CT or MRI for medical use?
"This is a Phase 2 trial, meaning that while there is some data indicating the safety of Ga-HBED-iPSMA PET with CT or MRI, there is no data yet supporting efficacy. Our team at Power has given it a score of 2."
Answered by AI
Are patients still being signed up for this research project?
"Unfortunately, this study is no longer enrolling patients. According to the latest update on clinicaltrials.gov, the last date for recruitment was August 1st, 2022. Although this trial has completed patient enrollment, there are 1388 other trials that are still recruiting patients."
Answered by AI
Is this trial being overseen by more than one institution?
"Currently, there are 7 locations for this trial running: Memoral Sloan Kettering Monmouth (Consent only) in Middletown, Memoral Sloan Kettering Basking Ridge (Consent only) in Basking Ridge, and Memorial Sloan Kettering Commack (Consent only), among others."
Answered by AI
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