18f-dcfbc pet/ct in prostate cancer

Conditions: Prostatic Neoplasms; Prostate Cancer

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.

background * prostate cancer is the second leading cause of cancer deaths in american men. * current methods of imaging advanced prostate cancer (computed tomography ((ct) and bone scan) are non specific and new, more specific molecular imaging probes are sought. * many prostate cancers express the prostate specific membrane antigen (psma) a transmembrane protein with n-acetylated alpha-linked acidic dipeptidase (naaladase) enzymatic activity. psma is also expressed in angiogenesis but otherwise has limited expression in normal tissue. * n-\[n-\[(s)-1,3-dicarboxypropyl\]carbamoyl\]-4-(18)f-fluorobenzyl-l-cysteine ((18)f-dcfbc) (18f-dcfbc) is a radiolabeled positron emission tomography (pet) agent which binds with high affinity to psma and through whole-body non-invasive functional imaging, may provide new information on the expression of psma. primary objective - to assess the ability of 18f-dcfbc to differentiate between tumorous and nontumorous tissues in localized, recurrent (based on rising prostatic-specific antigen ((psa) post treatment) and metastatic prostate cancer eligibility * subject is greater than or equal to 18 years old * eastern cooperative oncology group (ecog) 0-2 with adenocarcinoma of the prostate and fits criteria for one of the following: * arm 1 -- patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater. ---a multiparametric magnetic resonance imaging (mri) (standard of care at the national institutes of health ((nih) clinical center) must be performed within 4 months of18f-dcfbc injection with findings suggestive for prostate cancer and confirmed with histopathology. * arm 2 * patients with biochemical prostate cancer relapse after definitive treatment * for patients status post radiation therapy for prostate cancer, a psa increase from post radiation therapy nadir * or * for patients status post prostatectomy, any psa \>/=0.2 ng/ml * nonspecific or no evidence for disease on standard imaging modality * arm 3 * patients with identifiable metastatic disease on a conventional imaging modality. if only soft tissue metastasis, one lesion must measure 6mm or greater. patients must have confirmation of prostate cancer prior to 18f-dcfbc imaging. design this is a single site 3-arm study enrolling a total of 110 evaluable patients: arm 1 will include 12 patients with presumed localized prostate cancer scheduled to undergo prostatectomy or biopsy within 4 months of enrollment; arm 2 will include 78 patients with biochemical recurrence without evidence of metastasis on conventional imaging; and arm 3 will include 20 patients with known metastatic disease who may or may not be on or/scheduled to begin therapeutic intervention. patients with presumed localized disease will undergo a standard of care, clinical multiparametric endorectal coil mri in the national cancer institute (nci) molecular imaging clinic within 4 months of screening. patients in arm 3 will undergo 2 imaging sessions: baseline and 4-6 month follow-up. clinical records (including psa) and treatment (if any) that occurred in the imaging interval must be available. all patients in arm 3 will also undergo na18f pet/ct for evaluation of bone metastases as part of this protocol. in order to allow for a small number of nonevaluable patients, the accrual ceiling will be set at 125.

Eligibility 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

Keywords: prostate specific membrane antigen radiolabeled pet agent imaging naf