A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, & [18F]

Status Completed

Clinical Trial Summary

The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET) imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane Antigen (PSMA) and is designed to detect prostate tumors.

Clinical Trial Description

The sponsor has developed a PET imaging agent, CTT1057, labeled with 18F, that is based on a small molecule core and targets an extracellular region of PSMA with high affinity. Although comparable to other inhibitors in terms of affinity for PSMA, this unique class of phosphoramidate agents are the only known irreversible PSMA inhibitors. Due to its irreversible binding to PSMA and rapid uptake by PSMA-expressing prostate cancer cells, accumulation at the cancer target is expected to be rapid, specific and sensitive.

Twenty patients will be enrolled in parallel in two cohorts:

- (Cohort A) Patients with prostate cancer prior to radical prostatectomy (N = 5).

- (Cohort B) Patients with evidence of metastatic castration-resistant prostate cancer (N = 15)

Participants receive a single intravenous (IV) dose (370 MBq, or 10 mCi) of CTT1057 in this first-in-human trial. Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. The 5 patients in the pre-prostatectomy cohort will comprise the dosimetry/pharmacokinetic (PK) cohort to establish organ dosimetry and PK profile. Patients in cohort A will undergo planned radical prostatectomy (plus lymph node dissection) within 12 weeks following CTT1057 PET/MR. Patients in cohort B (metastatic prostate cancer) will have the option for metastatic tumor biopsy following CTT1057 PET imaging.

The one-time nominal injected dose will be 370 MBq (10 mCi). Estimated mass dose is 20 µg of CTT1057. Dose will be in a volume of 3 - 5 mL, and will be injected intravenously as a bolus injection.

Vital signs, adverse event assessment, and 12 lead ECGs will be performed on day 1 before and after dosing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02916537
Study type	Interventional
Source	Cancer Targeted Technology
Contact
Status	Completed
Phase	Phase 1
Start date	September 2016
Completion date	August 28, 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05540392` - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues	Phase 1/Phase 2
Recruiting	`NCT05613023` - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT	Phase 3
Recruiting	`NCT05156424` - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer	Phase 1/Phase 2
Completed	`NCT03177759` - Living With Prostate Cancer (LPC)
Completed	`NCT01331083` - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer	Phase 2
Recruiting	`NCT05540782` - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting	`NCT04742361` - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer	Phase 3
Completed	`NCT04400656` - PROState Pathway Embedded Comparative Trial
Completed	`NCT02282644` - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry	N/A
Recruiting	`NCT06037954` - A Study of Mental Health Care in People With Cancer	N/A
Recruiting	`NCT06305832` - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer	Phase 2
Recruiting	`NCT05761093` - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed	`NCT04838626` - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection	Phase 2/Phase 3
Recruiting	`NCT03101176` - Multiparametric Ultrasound Imaging in Prostate Cancer	N/A
Completed	`NCT03290417` - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer	N/A
Active, not recruiting	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed	`NCT01497925` - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer	Phase 1
Recruiting	`NCT03679819` - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed	`NCT03554317` - COMbination of Bipolar Androgen Therapy and Nivolumab	Phase 2
Completed	`NCT03271502` - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms