18F-DCFBC PET/CT in Prostate Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-12

Study Completion Date

2018-01-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer

NCT01815515

Metastatic Prostate Cancer

COMPLETED PHASE1/PHASE2

11C- and 18F-Choline PET/MR Imaging for Prostate Cancer

NCT02397408

Prostate Cancer

COMPLETED PHASE2

18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

NCT03824275

Prostatic Neoplasms

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

PET Scan in Treating Patients With Metastatic Prostate Cancer

NCT00002981

Prostate Cancer

COMPLETED NA

18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer

NCT02809690

Prostate Neoplasm

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostatic Neoplasms Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Suspected Localized Prostate Cancer

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

Group Type EXPERIMENTAL

18F DCFBC

Intervention Type 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

Patients with biochemical prostate cancer relapse after definitive treatment

Group Type EXPERIMENTAL

18F DCFBC

Intervention Type 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.

Known Metastatic Disease

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.

Group Type EXPERIMENTAL

18F DCFBC

Intervention Type 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.

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

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

18F DCFBC

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.

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Na 18F PET/CT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No