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Metastatic Prostate CancerPhase 1NCT02151760

Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

A Phase 1 study testing 18F-DCFPyL in people with Metastatic Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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

This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis. Read more about this study

Who is it for?
Ages 18 to 100 years, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
18F-DCFPyL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
May 2014to Apr 2020
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 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:
  • Greater than or equal to 18 years of age
  • Histological confirmation of prostate cancer
  • Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET
  • PSA ≥ 1.0 ng/mL
  • Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
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  • Platelet count > 50,000/mm3
  • Neutrophil count > 1,000/mm3
  • Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Who cannot join

  • Patients will be excluded from enrollment if any of the following apply:
  • Karnovsky performance status of < 60
  • Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
  • Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
  • Administered a radioisotope within 5 physical half-lives prior to study enrollment
  • Serum creatinine > 3 times the upper limit of normal
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  • Total bilirubin > 3 times the upper limit of normal
  • Liver Transaminases > 5times the upper limit of normal
  • Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
  • Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).
  • Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21287

Other trials in United States

About this study

This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis.

Read the detailed description

To assess the hypothesis that this new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging metastatic prostate cancer in ten patients diagnosed with metastatic prostate cancer.

Being tested
18F-DCFPyL
Keywords
Metastatic Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • 18F-DCFPyLDrug

    Also called 10.0 A bolus of less than or equal to 9 mCi (331 MBq) of 18F-DCFPyL will be injected into the IV line by slow push IV push.

Study groups in NCT02151760
Study groupRoleWhat they receive
18F-DCFPyLExperimentalNot described
Receives: Drug: 18F-DCFPyL

What is being measured

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

  1. PET/CT Detection of Metastatic Disease

    To comare diagnostic accuracy of 18-DCFPyL to CIM(CT and bone scintigraphy) for the detection of metastatic prostate cancer.

    Measured: 12 months

Timeline

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

  1. First posted30 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionApr 2020
  4. Study completionApr 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02151760
Sponsor's protocol ID
J1418
Other IDs
NA_00092956, P50CA103175
Status last verified
May 2020
First submitted
28 May 2014
Last updated
7 May 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 18F-DCFPyL in people with Metastatic Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 10 inclusion and 11 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 7 May 2020. 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?

PET/CT Detection of Metastatic Disease (time frame: 12 months). 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 NCT02151760.

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 7 May 2020.

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