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
- Age: minimum 18 Years maximum N/A
- Gender: Male
- 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.
- 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