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18F-labeled PET Imaging for Prostate Cancer

Phase 3

Recruiting

Led By Herbert Lepor, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to month 24

Awards & highlights

Study Summary

This trial at NYU Langone Health tests prostate specific antigen (PSA) levels after Radical Prostatectomy to identify disease recurrence, aiming to identify and treat early. Patients with positive findings will be offered salvage intervention.

Who is the study for?

This trial is for men aged 18-100 who've had prostate removal surgery and now have a PSA level over 0.2 ng/ml, indicating potential cancer recurrence. It's not for those with MRI contraindications, previous allergic reactions to rhPSMA-7.3 (18F), or refusal of PET/MRI scans.Check my eligibility

What is being tested?

The study tests the timing of a diagnostic agent called rhPSMA-7.3 (18F) in combination with PET MRI imaging to detect recurrent prostate cancer after surgery. It compares the effectiveness at two different PSA levels: >0.2 ng/ml and >0.5 ng/ml or one year later.See study design

What are the potential side effects?

Potential side effects may include reactions related to the diagnostic agent rhPSMA-7.3 (18F) such as allergies, and typical risks associated with undergoing PET MRI imaging like discomfort or anxiety during the scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Percentage of Positive PCa Screens

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with PSA > 0.2 ng/ml following Radical ProstatectomyExperimental Treatment2 Interventions

Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA >0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,704 Total Patients Enrolled

24 Trials studying Prostate Cancer

5,217 Patients Enrolled for Prostate Cancer

Blue Earth DiagnosticsIndustry Sponsor

38 Previous Clinical Trials

2,965 Total Patients Enrolled

10 Trials studying Prostate Cancer

1,305 Patients Enrolled for Prostate Cancer

Herbert Lepor, MDPrincipal InvestigatorNYU Langone Medical Center

2 Previous Clinical Trials

67 Total Patients Enrolled

2 Trials studying Prostate Cancer

67 Patients Enrolled for Prostate Cancer

Media Library

Patients with PSA > 0.2 ng/ml following Radical Prostatectomy Clinical Trial Eligibility Overview. Trial Name: NCT05678322 — Phase 3

Prostate Cancer Research Study Groups: Patients with PSA > 0.2 ng/ml following Radical Prostatectomy

Prostate Cancer Clinical Trial 2023: Patients with PSA > 0.2 ng/ml following Radical Prostatectomy Highlights & Side Effects. Trial Name: NCT05678322 — Phase 3

Patients with PSA > 0.2 ng/ml following Radical Prostatectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05678322 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there regulatory approval for the treatment of patients with PSA levels above 0.2 ng/ml after Radical Prostatectomy?

"The safety of individuals with PSA > 0.2 ng/ml following Radical Prostatectomy has been assigned a score of 3 by our team, indicating that there is ample clinical evidence to support the effectiveness and security of this treatment intervention."

Answered by AI

Are participants still being accepted into this investigation?

"As reported on clinicaltrials.gov, this particular trial is not currently recruiting participants for their research. The study was initially published in January 1st of 2023 and the last update happened nine days later. However, there are over a thousand other studies that are actively seeking volunteers right now."

Answered by AI

To what extent can individuals be eligible to join this study?

"This medical study is searching for 24 participants aged between 18 and 100 who have been diagnosed with prostate cancer. Additionally, to be eligible they must also meet certain prerequisites such as having a PSA reading that surpasses 0.2 ng/ml post-radiation therapy (RP)."

Answered by AI

Is eligibility for this trial contingent upon age, and if so, what is the upper limit?

"This clinical trial is open to any patient aged between 18 and 100. Concomitantly, there are 69 studies recruiting under-18s and 1297 research projects for those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy

2023. "Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05678322.