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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

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 below
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I am 18 years old or older.
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My prostate cancer was confirmed by a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
588,580 Total Patients Enrolled
133 Trials studying Prostate Cancer
50,419 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

Ga-HBED-iPSMA PET with CT or MRI Clinical Trial Eligibility Overview. Trial Name: NCT03204123 — Phase 2
Prostate Cancer Research Study Groups: Ga-HBED-iPSMA PET with CT or MRI, Ga-HBED-iPSMA PET with MRI
Prostate Cancer Clinical Trial 2023: Ga-HBED-iPSMA PET with CT or MRI Highlights & Side Effects. Trial Name: NCT03204123 — Phase 2
Ga-HBED-iPSMA PET with CT or MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT03204123 — Phase 2
~145 spots leftby Jul 2025
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