RECRUITING

Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT

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Conditions

Advanced Prostate CancerMetastatic Prostate CancerMetastatic Prostate Neuroendocrine CarcinomaPSMA-Low Castration Resistant Prostate Cancer

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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

This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features. The name of the study interventions are: * 18F-fluciclovine-PET/CT scan * Two research blood collections

Official Title

A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET/CT Imaging

Quick Facts

Study Start:2024-02-01
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06062745

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 CriteriaExclusion Criteria
  1. * Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET/CT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma/NE features and/or IHC staining for NE markers. Participants should have at least 5 metastatic lesions.
  2. * Must have either already had standard of care 68Ga-PSMA PET/CT scan or be planned for 68Ga-PSMA PET/CT scan before or after the planned 18F-fluciclovine-PET/CT.
  3. * Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants \<18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials.
  4. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  5. * Ability and willingness to comply with the study procedures.
  6. * The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET/CT scan is completed.
  7. * Ability to understand and the willingness to sign a written informed consent document
  1. * Participants with other known malignancy requiring treatment
  2. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.
  3. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  4. * Contraindications for PET/CT including:
  5. * Severe claustrophobia
  6. * Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk 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 Date2024-02-01
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2028-09-01

Terms related to this study

Keywords Provided by Researchers

  • Advanced Prostate Cancer
  • Metastatic Prostate Cancer
  • Metastatic Prostate Neuroendocrine Carcinoma
  • PSMA-Low Castration Resistant Prostate Cancer

Additional Relevant MeSH Terms

  • Advanced Prostate Cancer
  • Metastatic Prostate Cancer
  • Metastatic Prostate Neuroendocrine Carcinoma