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Pilot Study of 18F-DCFPyL-PSMA PET in Prostate Cancer

This study is looking at how well an imaging test, called 18F-DCFPyL-PSMA PET, can show the extent of prostate cancer in men who are about to receive treatment with 177Lu-Vipivotide Tetraxetan. You can join if you are an adult man with prostate cancer that has spread (metastatic castration-resistant prostate cancer) and are already planned to receive 177Lu-Vipivotide Tetraxetan therapy. You must also have at least one PSMA-avid lesion (a spot that lights up on a specific type of scan) on a recent 68Ga-PSMA-11 PSMA-PET scan. The main goal is to see what proportion of participants have PSMA-positive lesions detected by the 18F-DCFPyL-PSMA PET scan. The current recruitment status is unclear.

Study design
This is a single-arm pilot study, meaning all 30 participants will receive the same intervention. It is not specified if it is blinded.
What's involved
You would have one PET scan using 18F-DCFPyL and your medical records would be collected. Participation is expected to last about 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1 day after the scan. No further follow-up duration is specified.

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NCT06099093

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

Recruiting
PHASE4Ages 18+InterventionalDiagnostic
Brigham and Women's Hospital
~30 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:18F-DCFPyl

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with PSMA-Positive Lesion
Measured over 1 Day

Conditions

Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-resistant Prostate Carcinoma

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Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Heather Jacene, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Heather Jacene, MD
[email protected]
617-632-3767
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have histologically or cytologically confirmed prostate cancer.
Age ≥18 years.
Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET.
≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of study entry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy).
Ability and willingness to comply with the study procedures.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial.
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.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Contraindications to PET/CT, including severe claustrophobia.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL
Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.

What this trial measures

  • Proportion of Participants with PSMA-Positive Lesion1 Day

    Defined as the number of participants with at least 1 PSMA-positive lesion on 18F-DCFPyL PSMA-PET.