18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    300
  • sponsor
    Columbia University
Updated on 30 January 2021
ct scan
cancer
metastatic prostate cancer
pet/ct scan
prostate cancer metastatic
68ga-psma-11

Summary

PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, [18F] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Description

The investigators will conduct a prospective phase II/III study of 300 men diagnosed with prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations and undergo 18F- DCFPyL PET/CT.

[18F]DCFPyL will be used for study imaging.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate tumor, prostate tumors
Treatment 18F- DCFPyL PET/CT
Clinical Study IdentifierNCT03824275
SponsorColumbia University
Last Modified on30 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Malignant neoplasm of prostate?
Do you have any of these conditions: prostate tumor or Prostate Cancer or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate or prostate tumors or Prostatic disorder or P...?
Histologically confirmed diagnosis of prostate cancer
PSA 0.2ng/ml
Age 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 2 (karnofsky 60%)
Ability to understand and willingness to sign a written informed consent document
Wiling to comply with clinical trial instructions and requirements
Willing to cover the cost of PyL PET/CT imaging if funds are not available

Exclusion Criteria

History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
Presence of prostate brachytherapy implants unless approved by the PI
Administration of another radioisotope within five physical half-lives of trial enrollment
Radiation or chemotherapy within 2 weeks prior to trial enrollment
Serum creatinine > 3 times the upper limit of normal
Serum total bilirubin > 3 times the upper limit of normal
Aspartate transaminase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal
Inadequate venous access
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note