A Phase 2 interventional study of Enzalutamide capsule in Prostate Cancer, sponsored by CHU de Quebec-Universite Laval. Active, not recruiting at 4 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by CHU de Quebec-Universite Laval · Phase 2, Interventional, and Treatment
This study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging
Prostate cancer (PCa) is the most common solid organ cancer in North American men and is initially androgen sensitive. Therefore, castration and/or androgen receptor blockade remains the central palliative treatment once PCa has metastasized or failed to locoregional therapies. Because androgen deprivation therapy is not curative, all patients will eventually progress to the metastatic castration-resistant prostate cancer state. About 5% of prostate cancers will be metastatic by conventional imaging techniques at diagnosis while most patients achieving CRPC state will first be localized and then progress to metastatic state later in the disease course. Therefore, a significant proportion of patients will progress through an intermediary state of disease defined as the non-metastatic CRPC state (M0CRPC). Over the last year and a half, M0CRPC treatment landscape has completely changed with demonstrating the benefits of second-generation antiandrogens (darolutamide, enzalutamide and apalutamide) to prevent progression of M0CRPC patients. Enzalutamide have then been approved by the Federal Drug Administration and Health Canada for the treatment of M0CRPC.
On the other hand, conventional imaging techniques based on bone turnover (bone scan (BS)) or anatomical features (magnetic resonance imaging (MRI) or computed tomography (CT)) have important limitations and poor accuracy. Bone scans (BS) is the commonest imaging technique used to detect bone metastases in the clinics. BS does not image directly cancer cells, but the effect of cancer on the bone. Other pathologies such as fractures, degenerative arthritis and other benign bone lesions can also cause focal uptake on BS and lead to false-positive results. Another drawback of BS is its poor sensitivity to image small metastases confined to bone marrow. These limitations stress the importance to improve PCa imaging by using new imaging modalities.
Because novel agents targeting the androgen synthesis and receptor axis (e.g. enzalutamide), bone metastasis (radium-223) and microtubules assembly (docetaxel, cabazitaxel) have been shown to increase metastatic CRPC patients overall survival, a burning question is to determine if the non-metastatic CRPC status is real. There is growing evidence that newer imaging techniques using positron emission tomography can improve metastasis detection accuracy and may refine PCa patient prognostic stratification and treatment eligibility.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 50 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enrolled subjects will receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL Injection followed by a single PET/CT scan acquired at 1-2 hours post-dosing. After initial 18F-DCFPyL PET/CT, the patients with positive 18F-DCFPyL PET/CT imaging will be treated with enzalutamide (160 mg po id) for M0CRPC disease within less than two weeks. 18F-DCFPyL PET/CT scan will then be repeated 90 days after the start of enzalutamide treatment. A final follow-up imaging (18F-DCFPyL PET/CT) at progression or at the final follow-up imaging examination at 18 months after the new complete ICF or in September 2026 (whichever comes first) will be performed.
Drug: Enzalutamide capsule
160 mg po id
Also known as: Xantdi
Determine the percentage of patients presenting new metastatic lesions detected by 18F-DCFPyL-PSMA PET/CT in castration resistant prostate cancer patients presenting non metastatic, equivocal or oligometastatic (< 5 metastasis) disease
Number of patients presenting with metastases per compartment (bone, visceral, lymph node) determined by 18F-DCFPyL-PSMA PET/CT that were negative or equivocal on conventional imaging. determined by 18F-DCFPyL-PET/CT.
Time frame: Through study completion, an average of 1 year
Determine the number of discordant lesions between conventional and PSMA-PET/CT imaging in castration resistant prostate cancer patients presenting with non metastatic, equivocal or oligometastatic (< 5 metastasis) disease defined by conventional imagi
Number of metastases per compartment (bone, visceral, lymph node) that are discordant between conventional imaging and 18F-DCFPyL-PSMA -PET/CT.
Time frame: through study completion, an average of 1 year
Determine the percentage of patients showing 18F-DCFPyL-PSMA PET/CT active lesions at progression (V5) that were active on either baseline and 3-month PSMA-PET/CT (extension phase)
At V5, number of patients presenting with metastases determined by 18F-DCFPyL-PSMA PET/CT that were active on either baseline and 3-month PSMA-PET/CT
Time frame: through study extension phase completion, an average of 1 year
In patients with 18F-DCFPyL-PSMA PET/CT active lesions at progression (V5), determine the percentage of lesions that were NOT active on either baseline and 3-month PSMA-PET/CT (New lesions) (extension phase)
Number of metastases per compartment (bone, visceral, lymph node) at V5 imaging that were NOT active on either baseline and 3-month PSMA-PET/CT. Number of metastases per compartment (bone, visceral, lymph node) that were active on either baseline and 3-month PSMA-PET/CT.
Time frame: through study extension phase completion, an average of 1 year
Determine the intrapatient and interpatient 18F-DCFPyL-PSMA response rates defined by a 50% decrease in intralesional 18F-DCFPyL-PSMA uptake or 50% decrease in sum metastasis 18F-DCFPyL-PSMA uptake after 3 months of enzalutamide.
Determine the changes in 18F-DCFPyL-PSMA sum metastasis SUVmax (or any other radiomic PET parameter) for each patient and the changes of 18F-DCFPyL-PSMA SUVmax (or any other radiomic PET parameter) in each lesion after 3 months of enzalutamide.
Time frame: At the end of study completion, an average of 2 years
Determine the impact of 18F-DCFPyL-PSMA PET/CT at progression (V5) on patient's management. (Extension phase)
Management plan prior and after the last 18F-DCFPyL-PSMA PET/CT (V5)
Time frame: through study extension phase completion, an average of 1 year
In non-progressive patients defined by stable PSA, determine the percentage of patients showing active 18F-DCFPyL-PSMA PET/CT lesions at V5. (extension phases)
Number of patients presenting active 18F-DCFPyL-PSMA PET/CT lesions at V5 (among those who have not progressed).
Time frame: through study extension phase completion, an average of 1 year
Determine how 18F-DCFPyL-PSMA PET/CT radiomics at baseline or 3 months after enzalutamide start can predict time to biochemical progression under enzalutamide. (extension phase)
Metastases SUVmax (or any other radiomics PET parameter) for each patient at baseline (V1) and 3 months after enzalutamide start (V3). Date of enzalutamide start and of biochemical progression
Time frame: through study extension phase completion, an average of 1 year
Number and sites of new lesions detected by 18F-DCFPyL-PSMA PET/CT at several PSA thresholds
Number of metastasis per compartment (bone, visceral, lymph node) determined by 18F-DCFPyL-PET/CT when PSA is \<1 ng/mL, 1 to 5 ng/mL and \> 5 ng/mL.
Time frame: At the end of study completion, an average of 2 years
Determine the percentage of patients showing metastatic lesions with enough 18F-DCFPyL uptake (above that of the liver) to justify radioligand therapy before and 3 months after enzalutamide treatment.
Analyze if a patient shows one or several lesions with a 18F-DCFPyL uptake more than that of the liver.
Time frame: At the end of study completion, an average of 2 years
Determine clinical and radiomics criteria to distinguish patients presenting with flares at 3-months (visit 3) from those that had real progression at V5. (Extension phase)
Clinical and radiomics characteristics of patients that had ≥1 progressive lesion on visit 3 DCFPyL-PSMA PET/CT but sustained PSA-response for up to six months which defines a flare phenomena (section 15.4.2)
Time frame: through study extension phase completion, an average of 1 year
Determine the percentage of patients with oligo-progressive (<5 sites) disease based on 18F-DCFPyL-PSMA PET/CT at V5 (extension phase)
Number of patients presenting with oligo-progressive (\<5 sites) disease based on 18F-DCFPyL-PSMA PET/CT at V5.
Time frame: through study extension phase completion, an average of 1 year
Compare number of lesions determined by most recent conventional imaging (bone scintigraphy and CT-scan) with that of 18F-DCFPyL-PSMA PET/CT at V5 (extension phase)
Number of lesions per compartment (bone, visceral, lymph node) at V5 and the most recent conventional imaging and at 18F-DCFPyL-PSMA PET/CT at V5
Time frame: through study extension phase completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CHU de Quebec-Universite Laval