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RecruitingPhase 4

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

A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This research study involves a single PET scan using the imaging agent 18F-DCFPyL and the collection of information from medical records."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two PET scans, 18F-DCFPyL PSMA PET and 68Ga-PSMA-11 PET/CT, to see how well they show the amount and spread of prostate cancer. It is for adults with prostate cancer who plan to receive 177Lu-Vipivotide Tetraxetan treatment after the study scan.

The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • Your prostate cancer was confirmed by testing tissue or cells.
  • You plan to receive 177Lu-Vipivotide Tetraxetan as part of your usual care after the study scan.
  • A 68Ga-PSMA-11 PET scan within 120 days before joining showed at least one cancer spot that took up the PSMA tracer.
  • You are able and willing to follow the study steps.
  • You may have another past or current cancer if it and its treatment will not affect the study’s safety or results.
  • You agree to use birth control or avoid sex before joining and for 24 hours after the study scan.
  • You can understand the study and are willing to sign a consent form.

Who can't join

  • You have an illness that is not under control, such as an active infection, heart failure with symptoms, unstable chest pain, or an uneven heartbeat.
  • You cannot safely have a PET/CT scan, including because of a severe fear of tight spaces.
  • You have had an allergic reaction to a substance similar to 18F-DCFPyL.
  • The study team believes a past or current health problem could affect the results or add risk or burden for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (2)

MA