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

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ClinicalTrials.gov Identifier: NCT02916537
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Cancer Targeted Technology

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: CTT1057 Procedure: Prostatectomy Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA)
Study Start Date : September 2016
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A: Pre-prostatectomy patients
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
Single IV dose (370 MBq, or 10 mCi) of CTT1057 followed by combined PET/MR imaging (prostate + whole body).

Procedure: Prostatectomy
Radical prostatectomy with lymph node dissection

Experimental: Cohort B: Metastatic prostate cancer

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




Primary Outcome Measures :
  1. Adverse event frequency as graded by Common Toxicity Criteria version 4.03 [ Time Frame: 7 days from time of injection ]

Secondary Outcome Measures :
  1. Organ dosimetry/tissue uptake of CTT1057 as measured by PET/MR imaging of prostate cancer [ Time Frame: Up to six hours from time of injection ]
  2. Pharmacokinetic profile of CTT1057 as measured by radiotracer detection in blood samples [ Time Frame: Up to four hours from time of injection ]
  3. Level of CTT1057 uptake on PET/MR imaging of localized prostate cancer with PSMA protein expression by immunohistochemistry from subsequent radical prostatectomy specimens [ Time Frame: 12 weeks ]
  4. Optimal Standardized Uptake Value (SUV) ratio threshold on CTT1057 PET/MR for discriminating tumor pathology from primary prostate cancer tissue [ Time Frame: 4 hours ]
  5. Sensitivity and specificity of CTT1057 PET imaging on a lesion-by-lesion basis as compared with standard imaging in metastatic prostate cancer [ Time Frame: 4 hours ]
  6. Number of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans [ Time Frame: 4 hours ]
  7. Location of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans [ Time Frame: 4 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916537


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Cancer Targeted Technology
University of California, San Francisco
Investigators
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Study Chair: Beatrice Langton-Webster, PhD Cancer Targeted Technology
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Responsible Party: Cancer Targeted Technology
ClinicalTrials.gov Identifier: NCT02916537    
Other Study ID Numbers: 1057-101
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cancer Targeted Technology:
prostate cancer
prostate specific membrane antigen
prostate neoplasms
metastatic prostate cancer
prostatic hyperplasia
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases