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New scan may forecast prostate cancer relapse

NCT ID NCT03976843

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

175 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 99 years

Sex

Male participants only

Healthy volunteers

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

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

  • Brigham and Women s Hospital

    Boston, Massachusetts, 02115, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107-6541, United States

  • Tulane University

    New Orleans, Louisiana, 70112-2699, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.