18F- DCFPyL PET/CT for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Columbia University Irving Medical Center, New York, NY
Prostate Cancer
18F- DCFPyL PET/CT - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a new imaging agent may be able to help predict which prostate cancer patients will respond to therapy.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether 18F- DCFPyL PET/CT will improve 1 primary outcome, 2 secondary outcomes, and 2 other outcomes in patients with Prostate Cancer. Measurement will happen over the course of 3.5 years.

3.5 years
To characterize ctDNA and exosomes in patients with prostate cancer
To determine correlation with ctDNA and/or exosome levels with disease burden
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones
To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
18F- DCFPyL PET/CT

This trial requires 129 total participants across 2 different treatment groups

This trial involves 2 different treatments. 18F- DCFPyL PET/CT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

18F- DCFPyL PET/CT
Drug
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 including complete blood count (CBC), serum chemistries, hepatic panel, lactate dehydrogenase (LDH), and PSA. Liquid biopsies for circulating tumor DNA (ctDNA) and exosome analysis will occur at the same time. Subjects will then undergo 18F- DCFPyL PET/CT.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3.5 years for reporting.

Who is running the study

Principal Investigator
M. D.
Prof. Matthew Dallos, Associate Clinical Professor of Medicine
Columbia University

Closest Location

Columbia University Irving Medical Center - New York, NY

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The individual has a score of 60 or higher on the Karnofsky Performance Status Scale, indicating that they are able to carry out most of their normal activities. show original
I am willing to comply with all instructions and requirements for the clinical trial. show original
PyL Imaging is willing to cover the costs for PET/CT imaging for any individuals who may not have the financial resources to pay for the procedure. show original
Diagnosis of prostate cancer that has been confirmed by examining a sample of the prostate under a microscope. show original
PSA ≥ 0.2ng/ml
Age ≥ 18 years of age
Ability to understand and willingness to sign a written informed consent document

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes prostate cancer?

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Prostate cancer is more common in men of African descent, who have increased risk from the prostate specific antigen assay. This may be because of an increased risk from high levels of prostate specific antigen.

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Can prostate cancer be cured?

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The cure rate of prostate cancer is approximately 75% with curative treatment if all available treatment options are used. Patients with high risk disease tend to have a poor prognosis, and therefore, curative treatment should only be considered for those patients.

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What are common treatments for prostate cancer?

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Common treatment for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s include surgery, chemotherapy, radiation therapies, or hormonal therapy. There is no one-size-fits-all prostate treatment approach, and the treatment strategy depends on the type and extent of the growth of the tumor.

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What is prostate cancer?

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In men with a family history of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), early referral to a urologist is highly important. These men can benefit from early screening to avoid the inconvenience and anxiety. Prostate-specific antigen testing alone is not reliable enough to predict who will develop cancer. Screening men over the age of 50 years should be offered every 3 years.

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How many people get prostate cancer a year in the United States?

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If the current prostate cancer detection rates continue to rise, and no appreciable decline occurs in the mortality attributable to prostate cancer, more than 1,000 new cases of prostate cancer will be diagnosed every year.

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What are the signs of prostate cancer?

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Many symptoms of PCa and PCa-related symptoms can be mistaken with those of other common conditions, such as BPH and a urinary tract infection. Therefore, a complete history and physical examination can significantly increase the detection of PCa because it can help to distinguish between BPH and PCa.

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Is 18f- dcfpyl pet/ct safe for people?

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This case has highlighted uncertainties associated with the use of FDACP PET/CTs, as well as the potential risks of exposing the patient to ionizing radiation. The risk of an incidental finding of prostate cancer has to be considered when patients in good health undergo FDACP PET/CTs.

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What does 18f- dcfpyl pet/ct usually treat?

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A single administration of (18)F-dfpyl was well tolerated in patients with prostate cancer. Further studies are needed to understand its clinical impact. (18)F-dfpyl PET/CT may be a useful tool for the identification of clinically insignificant prostate cancer.

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What are the chances of developing prostate cancer?

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If a prostate cancer was not known before the age of 45 to 50 years, the chance of developing a prostate cancer is about 10%. If the prostate cancer is known before the age of 40 to 45 years, the chance of developing a prostate cancer at 45 to 50 years is 2.3%, but this number decreased with time, from 7.8 to 3.3%. After the age of 50 to 55 years, these numbers are lower, between 1.2% and 0.9%. The total number is between 3.4% and 2%, depending on the age of the patient.

Unverified Answer

Have there been other clinical trials involving 18f- dcfpyl pet/ct?

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Although there are not many publications in the literature concerning the PET/MRI of FDPC, many of these articles suggest the same role as (18)F-DACFPy PET/MRI for the detection of prostate cancer when PET/MRI alone is negative.

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Is 18f- dcfpyl pet/ct typically used in combination with any other treatments?

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Adding 18F-DCPP PET to the clinical workup does not seem to have an impact on the therapeutic decisions. The treatment decision is based on the tumor PET/CT findings alone and not on the 18F-DCPP PET PET/CT results alone.

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What is 18f- dcfpyl pet/ct?

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The present data support the concept of prostate specific membrane antigen-expressing LNCaP cells as a valid model for the metastatic (and possibly prostate specific antigen-expressing) cells and are consistent with the notion that dCF4 is a potential PET-labeled tracer for metastatic cell cancer.

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