Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655365
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2020-11-30
Brief Title:
Detecting Metastases by PyL PETCT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Detection and Monitoring of Metastasis by 18F-DCFPyL PETCT in Subjects Starting Enzalutamide for Untreated Castration Resistant Prostate Cancer and Negative Equivocal or Oligometastatic Disease on Conventional Imaging PROSTEP-002
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSTEP-002
Brief Summary:
This study aimed to evaluate the diagnostic performance of 18F-DCFPyL PyL PETCT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging
Detailed Description:
Prostate cancer PCa is the most common solid organ cancer in North American men and is initially androgen sensitive Therefore castration andor 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None