PSMA-based PET Imaging for Prostate Cancer

Recruiting at 1 trial location

Overseen By Phuoc Tran, M.D., Ph.D.

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must be taking: Radiation, ADT

Must not be taking: Chemotherapy, Hormone therapy

Disqualifiers: Pelvic radiation, Hemorrhagic cystitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2-3 months

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.

Research Team

Curtiland Deville, M.D.

Principal Investigator

The SKCCC at Johns Hopkins

Eligibility Criteria

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.

Inclusion Criteria

I am healthy enough for radiation and hormone therapy.

My prostate cancer is aggressive (Gleason score 8-10).

At least 10 days after most recent prostate biopsy

Exclusion Criteria

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

I am receiving chemotherapy for prostate cancer.

I am considering a trial treatment for prostate cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline DCFPyL PET-MRI fusion or PET/MRI imaging

1 week

1 visit (in-person)

Treatment

Participants receive 2-3 months of androgen deprivation therapy (ADT) with follow-up imaging

2-3 months

2 visits (in-person)

Follow-up Imaging

Participants undergo follow-up DCFPyL PET-MRI fusion or PET/MRI imaging to assess response to ADT

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 18F-DCFPyL

Trial Overview 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.

Participant Groups

Group I: DCFPyL PET-MRI fusion or PET/MRI Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+