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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met