18F-DCFBC PET/CT in Prostate Cancer

NCT02190279 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: 14014014-C-0140
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Neoplasms; Prostate Cancer

Keywords

Prostate Specific Membrane Antigen; Radiolabeled PET Agent; Imaging; NaF

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging

  Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.

  1 hour and 2 hour timepoints at baseline

• Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)

  Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.

  1 hour and 2 hour timepoints at baseline

Secondary Outcomes (6)

• Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

  Date treatment consent signed to date off study, approximately 42 months and 21 days

• Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease

  3 months

• Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)

  1 hour and 2 hour post injection (p.i.)

• Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy

  1 month

• Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland

  3 months

Study Arms (3)

Suspected Localized Prostate Cancer

EXPERIMENTAL

Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.

Drug: 18F DCFBC

Biochemical Recurrence

EXPERIMENTAL

Patients with biochemical prostate cancer relapse after definitive treatment

Drug: 18F DCFBC

Known Metastatic Disease

EXPERIMENTAL

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 investigational imaging.

Drug: 18F DCFBC; Drug: Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)

Interventions

18F DCFBC DRUG

Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.

Biochemical Recurrence; Known Metastatic Disease; Suspected Localized Prostate Cancer

Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT) DRUG

Also known as: Na 18F PET/CT

Known Metastatic Disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Mena 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 RESULT

• Turkbey 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 RESULT

• Harmon 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 RESULT

• Rowe 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 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

N-(N-((S)-1,3-Dicarboxypropyl)carbamoyl)-4-(18F)fluorobenzyl-L-cysteine; Sodium

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Results Point of Contact

• Title: Dr. Maria Liza Lindenberg
• Organization: National Cancer Institute

liza.lindenberg@nih.gov

240-760-6109

Study Officials

• Maria Liza Lindenberg, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2014
• First Posted: July 15, 2014
• Study Start: July 12, 2014
• Primary Completion: December 31, 2017
• Study Completion: January 11, 2018
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-04

Locations

US (1)