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Prostate CancerPhase 1NCT02916537

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

A Phase 1 study testing CTT1057 and Prostatectomy in people with Prostate Cancer, run by Cancer Targeted Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
CTT1057 and Prostatectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 2016to 28 Aug 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • - 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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)

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
CTT1057, Prostatectomy
Keywords
prostate cancer, prostate specific membrane antigen, prostate neoplasms, metastatic prostate cancer, prostatic hyperplasia
Medical subject headings
Prostatic Neoplasms, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTT1057Drug

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

  • ProstatectomyProcedure or surgery

    Radical prostatectomy with lymph node dissection

Study groups in NCT02916537
Study groupRoleWhat they receive
Cohort A: Pre-prostatectomy patientsExperimentalPatients 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.
Receives: Drug: CTT1057; Procedure: Prostatectomy
Cohort B: Metastatic prostate cancerExperimentalPatients 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.
Receives: Drug: CTT1057

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event frequency as graded by Common Toxicity Criteria version 4.03

    Measured: 7 days from time of injection

Secondary outcomes (7)

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

    Measured: Up to six hours from time of injection

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

    Measured: 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

    Measured: 12 weeks

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

    Measured: 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

    Measured: 4 hours

  6. Number of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans

    Measured: 4 hours

  7. Location of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion28 Aug 2017
  4. Study completion28 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02916537
Sponsor's protocol ID
1057-101
Status last verified
Nov 2017
First submitted
22 Sep 2016
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CTT1057 and Prostatectomy in people with Prostate Cancer, run by Cancer Targeted Technology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event frequency as graded by Common Toxicity Criteria version 4.03 (time frame: 7 days from time of injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02916537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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