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

NCT02916537 | Completed Phase 1

• 1 other identifier: 1057-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostate specific membrane antigen; prostate neoplasms; metastatic prostate cancer; prostatic hyperplasia

Outcome Measures

Primary Outcomes (1)

• Adverse event frequency as graded by Common Toxicity Criteria version 4.03

  7 days from time of injection

Secondary Outcomes (7)

• Organ dosimetry/tissue uptake of CTT1057 as measured by PET/MR imaging of prostate cancer

  Up to six hours from time of injection

• Pharmacokinetic profile of CTT1057 as measured by radiotracer detection in blood samples

  Up to four hours from time of injection

• Level of CTT1057 uptake on PET/MR imaging of localized prostate cancer with PSMA protein expression by immunohistochemistry from subsequent radical prostatectomy specimens

  12 weeks

• Optimal Standardized Uptake Value (SUV) ratio threshold on CTT1057 PET/MR for discriminating tumor pathology from primary prostate cancer tissue

  4 hours

• Sensitivity and specificity of CTT1057 PET imaging on a lesion-by-lesion basis as compared with standard imaging in metastatic prostate cancer

  4 hours

Study Arms (2)

Cohort A: Pre-prostatectomy patients

EXPERIMENTAL

Patients with prostate cancer prior to radical prostatectomy (N = 5). Single IV dose (370 MBq, or 10 mCi). Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. Patients in cohort A will undergo radical prostatectomy (plus lymph node dissection) within 12 weeks following CTT1057 PET/MR.

Drug: CTT1057; Procedure: Prostatectomy

Cohort B: Metastatic prostate cancer

EXPERIMENTAL

Patients with evidence of metastatic castration-resistant prostate cancer (N = 15). Single IV dose (370 MBq, or 10 mCi). Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. Patients in cohort B (metastatic prostate cancer) will have the option for metastatic tumor biopsy following CTT1057 PET imaging.

Drug: CTT1057

Interventions

CTT1057 DRUG

Single IV dose (370 MBq, or 10 mCi) of CTT1057 followed by combined PET/MR imaging (prostate + whole body).

Cohort A: Pre-prostatectomy patients; Cohort B: Metastatic prostate cancer

Prostatectomy PROCEDURE

Radical prostatectomy with lymph node dissection

Cohort A: Pre-prostatectomy patients

Eligibility Criteria

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

You may qualify if:

• Male patients age ≥18 years old
• Histologically confirmed adenocarcinoma of the prostate
• Adequate organ function including:
• \- Platelet count of \> 50,000/mm3
• \- Neutrophil count of \> 1000/mm3
• \- Serum Cr \< 1.5 x ULN or estimated GFR \> 60 ml/min based upon Cockroft-Gault equation
• \- Proteinuria \< 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio
• \- AST and ALT \< 2.5 x ULN (\< 5 x ULN in patients with known liver metastases)
• \- Total bilirubin \< 1.5 x ULN (\< 3 x ULN in patients with known/suspected Gilbert's disease)
• ECOG performance status of 0 or 1
• Able to provide written informed consent and willing to comply with protocol requirements
• No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
• For men of childbearing potential, the use of effective contraceptive methods during the trial and within 6 months following radiotracer injection
• Cohort A only (N = 5 evaluable patients):- Planned radical prostatectomy within 12 weeks following protocol scan
• \- No androgen deprivation, anti-androgen therapy, chemotherapy, or investigational systemic therapy prior to CTT1057 PET imaging

You may not qualify if:

• Inadequate venous access per assessment of treating health care provider
• Receipt of radioisotope within 5 physical half lives prior to trial enrollment
• Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days
• Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
• Histologic evidence of small cell prostate cancer or neuroendocrine differentiation in \> 50% of biopsy tissue

Sponsors & Collaborators

• Cancer Targeted Technology: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Interventions

Prostatectomy

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)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Beatrice Langton-Webster, PhD

  Cancer Targeted Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 27, 2016
• Study Start: September 1, 2016
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)