Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03976843

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

• Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory.
• Must have prostate cancer with high risk features defined as:
• Gleason 8 and higher OR
• PSA > 20 ng/mL OR
• Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
• Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT
• Men age greater than or equal to 18 years.
• ECOG performance status <2
• Patients must have adequate organ and marrow function as defined below:
• Hemoglobin greater than or equal to 9 g/dL
• leukocytes greater than or equal to 3,000/mcL
• platelets greater than or equal to 100,000/mcL
• total bilirubin <2 X normal institutional limits
• AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits
• creatinine <2 X normal institutional limits OR eGFR greater than or equal to 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• Ability of subject to understand and the willingness to sign a written informed consent document.
• Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible.
• Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT

Exclusion Criteria:

• Any investigational agents in the past 28 days prior to enrollment.
• Clinical stage T4 (tumor invades adjacent structures except seminal vesicles).
• Distant metastatic disease on conventional imaging studies (computed tomography (CT)) of the abdomen and pelvis and bone scan. NaF PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds, pelvic lymph nodes below 2 cm in the short axis are allowed.
• Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry.
• Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy.
• Contraindication to MRI or PET:
• Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry
• Prior reaction to 18F-DCFPyL
• Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T
• Severe claustrophobia unresponsive to oral anxiolytics
• 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.
• Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy.
• A malignancy within the past 3 years for which prostatectomy is a contraindication.
• Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging.
• PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with Gallium.
• Unable to refrain from fathering a child or donating sperm for 10 days after each 18FDCFPyL injection.

View trial on ClinicalTrials.gov