New scan spots prostate cancer that standard tests miss
NCT ID NCT04655365
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
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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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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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: * 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
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CHU de Québec-Université Laval
Québec, Quebec, Canada
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CHUM
Montreal, Quebec, H2X 0A9, Canada
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CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1J 3H5, Canada
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CUSM
Montreal, Quebec, H3H 2R9,, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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?