← Back to Search

PSMA-based PET Imaging for Prostate Cancer

Phase < 1

Waitlist Available

Led By Curtiland Deville, 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

Must not have

Hemorrhagic cystitis or active prostatitis

Chemotherapy for prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and then at 2-3 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have bleeding in my bladder or an active prostate infection.

Select...

I am receiving chemotherapy for prostate cancer.

Select...

I am considering a trial treatment for prostate cancer.

Select...

I have had radiation therapy to my pelvic area before.

Select...

I am undergoing hormone deprivation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and then at 2-3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate differences

Secondary study objectives

All cause DCFPyL PET-MRI fusion or PET/MRI toxicity

Biomarker changes

Gene expression changes

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met