18F-DCFPyL Imaging for Prostate Cancer

Overseen by Steve Y Cho, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.

Research Team

Steve Y Cho, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for men with prostate cancer, who may have metastatic disease and are fit for a prostatectomy. It includes those newly diagnosed or undergoing biopsy evaluation, with no recent chemotherapy or investigational therapy. Participants should not have had prior pelvic radiation and must be able to undergo PET/CT scans.

Inclusion Criteria

Two consecutive rising PSA values (Sub-Study 3 only)

My prostate cancer biopsy shows a Gleason score of 6 or higher with more than 2 positive cores.

I am a candidate for and can safely undergo prostate surgery.

Exclusion Criteria

I haven't had any cancer except for some skin or superficial bladder cancers in the last 2 years.

I am receiving hormone therapy for prostate cancer.

My prostate surgery is not scheduled more than 12 hours after imaging.

Treatment Details

Interventions

• 18F-DCFPyL PET (Radiopharmaceutical)

Trial Overview The study tests the effectiveness of a new imaging biomarker called 18F-DCFPyL PET in detecting, tracking progression, and recurrence of prostate cancer. The goal is to distinguish between aggressive and indolent cancer types to tailor treatment plans.

Participant Groups

Group I: 18F-DCFPyL PET Experimental Treatment 1 Intervention

Four separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine