New scan may forecast prostate cancer relapse
NCT ID NCT03976843
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 10 times
Summary
This study tests whether a special PET scan, done before prostate removal surgery, can predict if prostate cancer will come back. About 175 men with high-risk prostate cancer will get the scan, then have surgery, and be followed for up to 5 years. The goal is to see if this scan is better than standard imaging at forecasting cancer return.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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175 people
The number who actually took part.
- Started
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Dec 2019
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory. * Must have prostate cancer with high risk features defined as: * Gleason 8 and higher OR * PSA \> 20 ng/mL OR * Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b * Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT * Men age greater than or equal to 18 years. * ECOG performance status \<2 * Patients must have adequate organ and marrow function as defined below: * Hemoglobin greater than or equal to 9 g/dL * leukocytes greater than or equal to 3,000/mcL * platelets greater than or equal to 100,000/mcL * total bilirubin \<2 X normal institutional limits * AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits * creatinine \<2 X normal institutional limits OR eGFR greater than or equal to 50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal. (calculated via the MDRD equation) * Ability of subject to understand and the willingness to sign a written informed consent document. * Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible. * Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT EXCLUSION CRITERIA: * Any investigational agents in the past 28 days prior to enrollment. * Clinical stage T4 (tumor invades adjacent structures except seminal vesicles). * Distant metastatic disease on conventional imaging studies (computed tomography (CT)) of the abdomen and pelvis and bone scan. NaF PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds, pelvic lymph nodes below 2 cm in the short axis are allowed. * Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry. * Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy. * Contraindication to MRI or PET: * Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry * Prior reaction to 18F-DCFPyL * Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T * Severe claustrophobia unresponsive to oral anxiolytics * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy. * A malignancy within the past 3 years for which prostatectomy is a contraindication. * Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging. * PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with Gallium. * Unable to refrain from fathering a child or donating sperm for 10 days after each 18F-DCFPyL injection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women s Hospital
Boston, Massachusetts, 02115, United States
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Johns Hopkins University
Baltimore, Maryland, 21205, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-6541, United States
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Tulane University
New Orleans, Louisiana, 70112-2699, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?