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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jun 8, 2017

Keywords

ClinConnect Summary

Background:

* Prostate cancer (PCa) is the second leading cause of cancer death in American males.
* Patients with high risk but apparently localized disease are often understaged because disease beyond the prostate is not well detected and thus leads to overtreatment with prostatectomy
* Recurrence of PCa after surgery or radiation is very common and sometimes progresses to death.
* Early intervention for recurrence has been shown to be of benefit but current methods of localizing recurrence are either insensitive (CT), non-specific (MRI) or both (bone scan). Many prostate cancers express...

Gender

MALE

Eligibility criteria

• * 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 (including those receiving androgen deprivation therapy) 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
• • Participants must be co-enrolled on a MIB, UOB, GMB or ROB protocol.
• • The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason, individuals 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.
• • Serum creatinine greater than 2 times the upper limit of normal.