RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-04-01

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06099093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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.

Inclusion Criteria

Exclusion 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.
* 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.

* 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.

Contacts and Locations

Study Contact

Heather Jacene, MD

CONTACT

617-632-3767

hjacene@partners.org

Principal Investigator

Heather Jacene, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Brigham and Womens Hospital

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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