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PSMA-Based PET Imaging for Prostate Cancer

Phase 2

Recruiting

Led By William L Dahut, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Men age greater than or equal to 18 years.

Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years

Awards & highlights

Study Summary

This trial is testing if a PET/CT scan can help doctors better predict if prostate cancer will return after surgery.

Who is the study for?

Men over 18 with high-risk prostate cancer that's likely still in the prostate but could have spread. They must be healthy enough for surgery, able to undergo certain scans and biopsies if needed, and not have had any prior treatments or other cancers within 3 years.Check my eligibility

What is being tested?

The trial is testing a new PET/CT scan using the tracer 18F-DCFPyL before removing the prostate gland to see if it can predict cancer recurrence better than current methods. Participants will be followed up for five years after surgery.See study design

What are the potential side effects?

Potential side effects from the radiotracer injection may include allergic reactions or discomfort at the injection site. The PET/CT scan itself is generally safe but may cause anxiety or discomfort due to lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 18 or older.

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I am planning to have surgery to remove my prostate and lymph nodes.

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My blood and organ functions are within the required ranges.

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My prostate cancer is high risk with a Gleason score of 8 or higher, PSA over 20, or it has spread beyond the prostate.

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My prostate cancer diagnosis was confirmed by a certified lab.

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I can do most of my daily activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

progression free survival

Side effects data

From 2019 Phase 3 trial • 208 Patients • NCT03739684

Headache

Fatigue

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

18F-DCFPyL Injection

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/18F-DCFPyL PET/CT + radical prostatectomyExperimental Treatment1 Intervention

18F-DCFPyL PET/CT with radical prostatectomy and lymphadenectomy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-DCFPyL

2019

Completed Phase 3

~350

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,663 Previous Clinical Trials

40,925,704 Total Patients Enrolled

560 Trials studying Prostate Cancer

506,894 Patients Enrolled for Prostate Cancer

William L Dahut, M.D.Principal InvestigatorNational Cancer Institute (NCI)

11 Previous Clinical Trials

3,536 Total Patients Enrolled

6 Trials studying Prostate Cancer

2,302 Patients Enrolled for Prostate Cancer

Fatima H Karzai, M.D.Principal InvestigatorNational Cancer Institute (NCI)

4 Previous Clinical Trials

2,512 Total Patients Enrolled

1 Trials studying Prostate Cancer

2,000 Patients Enrolled for Prostate Cancer

Media Library

18F-DCFPyL Clinical Trial Eligibility Overview. Trial Name: NCT03976843 — Phase 2

Prostate Cancer Research Study Groups: 1/18F-DCFPyL PET/CT + radical prostatectomy

Prostate Cancer Clinical Trial 2023: 18F-DCFPyL Highlights & Side Effects. Trial Name: NCT03976843 — Phase 2

18F-DCFPyL 2023 Treatment Timeline for Medical Study. Trial Name: NCT03976843 — Phase 2

Frequently Asked Questions

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

What is the cap on patient enrollment in this clinical trial?

"This research trial needs 200 participants who meet its eligibility requirements. The study is available in multiple medical facilities, including Thomas Jefferson University and Johns Hopkins University respectively located in Philadelphia and Baltimore."

Answered by AI

Is it still possible to join this research initiative?

"Correct. According to records available on clinicaltrials.gov, this medical trial began recruiting patients as of December 4th 2019 and is still seeking enrolment from 200 volunteers across 7 sites."

Answered by AI

To what patient conditions is 18F-DCFPyL usually prescribed?

"To counter heightened levels of serum prostate specific antigen (psa), 18F-DCFPyL is regularly prescribed. Additionally, this medication can be used to treat suspected metastasis, positron emission tomography scans and recurrent occurrences of prostate cancer."

Answered by AI

Could you enumerate the past experiments conducted with 18F-DCFPyL?

"The initial research into 18F-DCFPyL was conducted at Johns Hopkins University in 2015 and since then 10 trials have been concluded. Currently, there are 18 active studies with several of these located near Philadelphia, Pennsylvania."

Answered by AI

How widespread is the implementation of this trial?

"Prospective enrollees for this clinical trial can be found at Thomas Jefferson University in Philadelphia, Johns Hopkins University in Baltimore and Tulane University in New Orleans. Additionally, there are 7 other participating sites across the country."

Answered by AI

Has the FDA sanctioned 18F-DCFPyL for use as a therapeutic?

"Our team at Power assigned a score of 2 to 18F-DCFPyL's safety due to the lack of efficacy data from its Phase 2 trial; however, there is some evidence affirming its relative security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

2019. "Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03976843.

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