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18F-DCFPyl PET Imaging for Prostate Cancer

Phase 4

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Progenics Pharmaceuticals, Inc.Industry Sponsor

33 Previous Clinical Trials

4,870 Total Patients Enrolled

17 Trials studying Prostate Cancer

2,304 Patients Enrolled for Prostate Cancer

Dana-Farber Cancer InstituteLead Sponsor

1,080 Previous Clinical Trials

341,203 Total Patients Enrolled

76 Trials studying Prostate Cancer

16,075 Patients Enrolled for Prostate Cancer

Heather Jacene, MDPrincipal InvestigatorDana-Farber Cancer Institute

3 Previous Clinical Trials

110 Total Patients Enrolled

Frequently Asked Questions

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

What risks, if any, are associated with 18F-DCFPYL-PSMA PET scans?

"18F-DCFPYL-PSMA PET has earned a score of 3 on our safety scale because it is already an approved method, which speaks to its Phase 4 trial status."

Answered by AI

Are researchers still recruiting volunteers for this clinical trial?

"According to clinicaltrials.gov, the recruitment for this trial has concluded; the original post was made on April 1st 2024 and last revised October 19th 2023. Despite its closure, a wealth of other studies remain open with 1364 actively seeking out new participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan

Heather A. Jacene, MD 2024. "Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06099093.