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18F-DCFPyl PET Imaging for Prostate Cancer

Phase 4
Recruiting
Led By Heather Jacene, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan
Participants must have histologically or cytologically confirmed prostate cancer
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Summary

This trial looks at whether a new imaging test can help show how far prostate cancer has spread, compared to an existing scan.

Who is the study for?
This trial is for adults with confirmed prostate cancer who are set to receive standard 177Lu-Vipivotide Tetraxetan therapy. They must have shown a positive response on a previous diagnostic scan and be willing to use birth control. People with severe illnesses, allergies to similar drugs, or conditions that could affect the study's outcome can't participate.
What is being tested?
The study tests how well an imaging test called 18F-DCFPyL PSMA-PET can show the spread of prostate cancer compared to another scan type (68Ga-PSMA-11 PET/CT). Participants will undergo this new imaging procedure before their planned therapy.
What are the potential side effects?
While specific side effects aren't listed for the imaging agent being tested (18F-DCFPyL), radiopharmaceuticals may cause reactions at injection sites, nausea, or allergic responses in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control or abstain from sex for 24 hours after the PSMA-PET scan.
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My prostate cancer diagnosis was confirmed through lab tests.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any uncontrolled illnesses like infections or heart problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants with PSMA-Positive Lesion

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-DCFPYL-PSMA PETExperimental Treatment1 Intervention
Study procedures will be conducted as follows: * Baseline screening visit with PSMA-PET/CT scan with Ga-PSMA-11. * In-clinic visit with exam and PSMA-PET/CT scan with 18F-DCFPyl per standard institutional procedures. * Standard of care therapy. * Follow up every 3 months via chart review for 12 months, with the purpose of seeing how participants respond to 177Luvipivotide tetraxetan treatment.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
353,067 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,668 Patients Enrolled for Prostate Cancer
Progenics Pharmaceuticals, Inc.Industry Sponsor
33 Previous Clinical Trials
4,328 Total Patients Enrolled
17 Trials studying Prostate Cancer
1,762 Patients Enrolled for Prostate Cancer
Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,491,005 Total Patients Enrolled
22 Trials studying Prostate Cancer
32,772 Patients Enrolled for Prostate Cancer
~7 spots leftby Dec 2024
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