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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
160 mg po id
CHUM
Montreal, Quebec, Canada
CUSM
Montreal, Quebec, Canada
CHU de Québec-Université Laval
Québec, Quebec, Canada
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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