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New scan spots prostate cancer that standard tests miss

NCT ID NCT04655365

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a special PET scan (18F-DCFPyL) to see if it can find prostate cancer spread that standard scans miss. Fifty men with castration-resistant prostate cancer starting enzalutamide will get the new scan. The goal is to better detect and monitor metastases, which could help guide treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
18F-DCFPyL (a radioactive tracer for PET scans) and enzalutamide (a hormone therapy drug)
What this could lead to
If successful, this could improve how doctors detect and monitor prostate cancer spread, leading to more personalized treatment decisions.
What could go wrong
This is a small, early-phase study focused on imaging accuracy, not on treatment outcomes. The new scan may not change patient survival or quality of life.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: * Histologically confirmed adenocarcinoma of the prostate per original diagnosis, with undergoing androgen deprivation therapy such as prior bilateral orchiectomy or surgical castration or LHRH-agonists/LHRH-antagonists. * Suspected recurrence of prostate cancer based on rising PSA under androgen deprivation therapy. Recurrent castration resistant prostate cancer patients are defined by a rising PSA \>1 ng/mL under ADT or surgical castration and with testosterone castration levels \< 1.7 nM (PCWG3 criteria). * Negative, equivocal findings or oligometastatic disease (\< 5) for prostate cancer on conventional imaging bone scan AND 2) abdomen-pelvis CT/MRI and chest CT or FDG-PET/CT or 18F-NaF PET/CT performed as standard of care workup within 90 days of signing the ICF. * The subject is candidate for second line androgen axis targeted inhibitors such as enzalutamide and planned to receive it. * Life expectancy ≥6 months as determined by the investigator * Able and willing to provide signed informed consent and comply with protocol requirement * PSA doubling time less or equal to 10 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. * Able to swallow the study drug and comply with study requirements. Exclusion Criteria: * Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to study drug injection. * Receipt of investigational drug therapy for prostate cancer within 60 days of Day 1. * Known or suspected brain metastasis or active leptomeningeal disease. * Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer. * History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness (unless of cardiac origin) or transient ischemic attack within 12 months before enrollment. * Major surgery within 4 weeks before randomization date. * Absolute neutrophil count \< 1000/μL, platelet count \< 100,000/μL, or hemoglobin \< 10 g/dL (6.2 mmol/L) at screening. * Total bilirubin ≥ 1.5-times the upper limit of normal or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5-times the upper limit of normal at screening. * Creatinine \> 2 mg/dL (177 μmol/L) at screening. * Albumin \< 3.0 g/dL (30 g/L) at screening. * Clinically significant cardiovascular disease * Gastrointestinal disorder affecting absorption. * Ongoing drug or alcohol abuse as per investigator judgment. * Subject has received any investigational radioactive agent within 28 days or 5 half-lives, whichever is longer, prior to screening. * Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completing the study. * Contraindication to enzalutamide * Treatment with specific (5-α reductase inhibitors, estrogens, cyproterone actetate, biologic agents with antitumor activity, systemic glucocorticoids, androgens, ...) within 4 weeks of day 1 and during the study treatment period

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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

  • CHU de Québec-Université Laval

    Québec, Quebec, Canada

  • CHUM

    Montreal, Quebec, H2X 0A9, Canada

  • CIUSSS de l'Estrie - CHUS

    Sherbrooke, Quebec, J1J 3H5, Canada

  • CUSM

    Montreal, Quebec, H3H 2R9,, Canada

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