18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer


Condition: Prostate Neoplasms, Prostatic Cancer, Prostate Cancer, Cancer Of Prostate, Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03181867

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Age greater than or equal to 18 years old
  • Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Histologically confirmed adenocarcinoma of the prostate
  • Patients fit criteria for one of the following categories:
  • Cohort 1 known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage >T2c) with evidence of disease on standard imaging, OR
  • Cohort 2 nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/mL Patients must be willing to undergo mandatory research biopsy
  • The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason, men must agree to use adequate contraception with their partner (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 2 months after 18F-DCFPyL scan. Should a partner become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform the treating physician immediately.

Exclusion Criteria:

  • Subjects for whom participating would significantly delay the scheduled standard of care therapy.
  • Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
  • Subjects with severe claustrophobia unresponsive to oral anxiolytics
  • Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
  • Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
  • Subjects receiving androgen deprivation therapy (ADT)
  • Serum creatinine greater than 2 times the upper limit of normal

View trial on ClinicalTrials.gov