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

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02916537

Run by

Cancer Targeted Technology

People needed

20

Starts

2016-09-01

Expected to finish

2017-08-28

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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
• Cohort B only:- Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan
• - Castration-resistant disease as defined by PCWG2 criteria
• - Must remain on androgen deprivation therapy for duration of trial if no prior bilateral orchiectomy

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

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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