18F-DCFBC PET/CT in Prostate Cancer

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.

Sex

Male

Minimum age

18 Years

Maximum age

99 Years

* 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

• RESULTMena E, Lindenberg ML, Shih JH, Adler S, Harmon S, Bergvall E, Citrin D, Dahut W, Ton AT, McKinney Y, Weaver J, Eclarinal P, Forest A, Afari G, Bhattacharyya S, Mease RC, Merino MJ, Pinto P, Wood BJ, Jacobs P, Pomper MG, Choyke PL, Turkbey B. Clinical impact of PSMA-based 18F-DCFBC PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. Eur J Nucl Med Mol Imaging. 2018 Jan;45(1):4-11. doi: 10.1007/s00259-017-3818-x. Epub 2017 Sep 11. PMID 28894899
• RESULTTurkbey B, Mena E, Lindenberg L, Adler S, Bednarova S, Berman R, Ton AT, McKinney Y, Eclarinal P, Hill C, Afari G, Bhattacharyya S, Mease RC, Merino MJ, Jacobs PM, Wood BJ, Pinto PA, Pomper MG, Choyke PL. 18F-DCFBC Prostate-Specific Membrane Antigen-Targeted PET/CT Imaging in Localized Prostate Cancer: Correlation With Multiparametric MRI and Histopathology. Clin Nucl Med. 2017 Oct;42(10):735-740. doi: 10.1097/RLU.0000000000001804. PMID 28806263
• RESULTHarmon SA, Bergvall E, Mena E, Shih JH, Adler S, McKinney Y, Mehralivand S, Citrin DE, Couvillon A, Madan RA, Gulley JL, Mease RC, Jacobs PM, Pomper MG, Turkbey B, Choyke PL, Lindenberg ML. A Prospective Comparison of 18F-Sodium Fluoride PET/CT and PSMA-Targeted 18F-DCFBC PET/CT in Metastatic Prostate Cancer. J Nucl Med. 2018 Nov;59(11):1665-1671. doi: 10.2967/jnumed.117.207373. Epub 2018 Mar 30. PMID 29602821
• DERIVEDRowe LS, Harmon S, Horn A, Shankavaram U, Roy S, Ning H, Lindenberg L, Mena E, Citrin DE, Choyke P, Turkbey B. Pattern of failure in prostate cancer previously treated with radical prostatectomy and post-operative radiotherapy: a secondary analysis of two prospective studies using novel molecular imaging techniques. Radiat Oncol. 2021 Feb 10;16(1):32. doi: 10.1186/s13014-020-01733-x. PMID 33568190