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PSMA-based PET Imaging for Prostate Cancer

Phase < 1
Waitlist Available
Led By Theodore DeWeese, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostate biopsy histology grade ≥ Gleason 8-10
Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and then at 2-3 months
Awards & highlights

Study Summary

This trial is testing a new radiotracer to see if it can help find prostate cancer.

Who is the study for?
This trial is for men over 18 with newly diagnosed prostate cancer, graded Gleason 8-10, who are planning to have radiation and ADT. They must be medically fit for these treatments and at least 10 days post-prostate biopsy. Men already on hormone therapy or those who've had chemotherapy, investigational therapies, or prior pelvic radiation can't participate.Check my eligibility
What is being tested?
The study tests a new radioactive imaging agent called 18F-DCFPyL in detecting prostate cancer within the gland and elsewhere in the body before surgery. It aims to improve how we visualize cancer using PET-MRI fusion techniques.See study design
What are the potential side effects?
Potential side effects may include reactions related to the radiotracer such as discomfort at injection site or allergic reactions, plus typical MRI-related issues like claustrophobia or discomfort from lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer is aggressive (Gleason score 8-10).
Select...
I am a man over 18 with new prostate cancer, planning on radiation and hormone therapy.
Select...
I have been recently diagnosed with prostate cancer confirmed by a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and then at 2-3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and then at 2-3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate differences
Secondary outcome measures
All cause DCFPyL PET-MRI fusion or PET/MRI toxicity
Biomarker changes
Gene expression changes
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: DCFPyL PET-MRI fusion or PET/MRIExperimental Treatment1 Intervention
Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,341 Total Patients Enrolled
565 Trials studying Prostate Cancer
529,064 Patients Enrolled for Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
561 Previous Clinical Trials
33,076 Total Patients Enrolled
58 Trials studying Prostate Cancer
3,428 Patients Enrolled for Prostate Cancer
Theodore DeWeese, M.D.Principal InvestigatorThe SKCCC at Johns Hopkins
1 Previous Clinical Trials
45 Total Patients Enrolled
1 Trials studying Prostate Cancer
45 Patients Enrolled for Prostate Cancer

Media Library

Pelvic DCFPyL PET-MRI fusion or PET/MRI Clinical Trial Eligibility Overview. Trial Name: NCT02420977 — Phase < 1
Prostate Cancer Research Study Groups: DCFPyL PET-MRI fusion or PET/MRI
Prostate Cancer Clinical Trial 2023: Pelvic DCFPyL PET-MRI fusion or PET/MRI Highlights & Side Effects. Trial Name: NCT02420977 — Phase < 1
Pelvic DCFPyL PET-MRI fusion or PET/MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT02420977 — Phase < 1
~4 spots leftby Jun 2025
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