Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer
3 other identifiers
interventional
23
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Dec 2018
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2015
CompletedFirst Posted
Study publicly available on registry
April 20, 2015
CompletedStudy Start
First participant enrolled
December 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMarch 19, 2025
March 1, 2025
5.2 years
April 15, 2015
March 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate differences
To compare the detection , sextant localization and response of DCFPyL PET-MRI fusion or PET/MRI before and after 2-3 months of ADT in men with biopsy-positive high-risk localized or locally advanced prostate cancer.
baseline and after 2-3 months
Secondary Outcomes (5)
Biomarker changes
Baseline and at 2=3 months
Metabolic tumor uptake changes
baseline and then at 2-3 months
Gene expression changes
Baseline and then at 2-3 months
Nodal metastatic disease changes
Baseline and then at 2-3 months
All cause DCFPyL PET-MRI fusion or PET/MRI toxicity
Baseline and then at 2-3 months
Study Arms (1)
DCFPyL PET-MRI fusion or PET/MRI
EXPERIMENTAL* 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
Interventions
* 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
Eligibility Criteria
You may qualify if:
- Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.
You may not qualify if:
- Newly diagnosed prostate cancer pathologically proven by prostate biopsy
- Prostate biopsy histology grade ≥ Gleason 8-10
- Patients considered as candidates for and medically fit to undergo radiation and ADT
- At least 10 days after most recent prostate biopsy
- Prior pelvic external beam radiation therapy or brachytherapy
- Chemotherapy for prostate cancer
- Hormone deprivation therapy
- Investigational therapy for prostate cancer
- Hemorrhagic cystitis or active prostatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Curtiland Deville
Baltimore, Maryland, 21287, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Curtiland Deville, M.D.
The SKCCC at Johns Hopkins
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2015
First Posted
April 20, 2015
Study Start
December 6, 2018
Primary Completion
March 1, 2024
Study Completion
March 1, 2025
Last Updated
March 19, 2025
Record last verified: 2025-03