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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
Biopsy proven adenocarcinoma of the prostate
Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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 below
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My prostate cancer was confirmed by a biopsy.
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I had surgery or radiation (or both) as my first cancer treatment.
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I was first treated with surgery or specific types of therapy for my condition.
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I have had treatment for cancer that came back or spread.
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I am 18 years old or older.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,920 Previous Clinical Trials
589,448 Total Patients Enrolled
131 Trials studying Prostate Cancer
64,733 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

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
~42 spots leftby Jun 2024