18F-DCFBC PET/CT in Prostate Cancer

• Status: Completed
• Trial end date: 2018-01-11
• Target enrollment: 0
• Participant gender: Male

Summary

Background:

• Prostate cancer is the second leading cause of cancer deaths in American men. A chemical called a radiotracer helps doctors get images of this type of cancer. Researchers want to test a radiotracer called N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC).

Objective:

• To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.

Eligibility:

• Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have relapsed, or has spread outside the prostate.

Design:

• Participants will be screened with physical exam and medical history. They will give a blood sample.

• Participants will be divided into three groups.

Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or biopsy at National Institutes of Health (NIH).

Group 2: people who had their prostate removed or had radiation therapy and now have a rising prostate-specific antigen (PSA) without other signs of disease.

Group 3: people whose cancer has spread to other areas of the body.

• Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on their back on the scanner table.

• Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a contrast agent injected through an intravenous line.

• Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21 days of the 18F-DCFBC scan to look for prostate cancer in the bone.

• Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.

• A few days after each scan, participants will be contacted for follow-up.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

• INCLUSION CRITERIA:

• Subject is greater than or equal to18 years old

• Platelet count > 50,000/mm^3

• Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.

• Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.

• Categories

• ARM 1 only

---For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging.

• ARM 2 only:

• For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir

• OR

• For patients status post prostatectomy, a PSA >/=0.2 ng/ml

• Nonspecific or no evidence for disease on standard imaging modality

• ARM 3 only:

• Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality. If only soft tissue metastasis, one lesion must measure at least 6mm or greater. Patients must have confirmation of prostate cancer prior to 18FDCFBC imaging

Note: A patient who is eligible for one arm, subsequently may cross-over into a different arm.

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 > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry

• Serum creatinine > 2 times the upper limit of normal

• Total bilirubin > 2 times the upper limit of normal

• Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal