Status:
COMPLETED
Influence of EMT on CTCs and Disease Progression in Prostate Cancer
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
The presence of circulating tumor cells (CTCs) in the blood of prostate cancer patients has been shown to be an important indicator of metastatic disease and poor prognosis. Additionally, changes in C...
Detailed Description
The presence of circulating tumor cells (CTCs) in the blood of prostate cancer patients has been shown to be an important indicator of metastatic disease and poor prognosis. Additionally, changes in C...
Eligibility Criteria
Inclusion
- Inclusion Criteria (all patients):
- histologically diagnosed prostate cancer
- signed informed consent
- HR-HSPC cohort
- previous prostatectomy
- previous treatment with androgen deprivation therapy for \<90 days and/or recommended but not yet started new line of androgen deprivation therapy
- adverse pathological findings (\>=1 of extracapsular extension, positive margins, and/or seminal vesicle invasion)
- documented evidence of biochemical failure following adjuvant/salvage radiation therapy
- PSA of \>1 ng/ml
- LV-mHSPC cohort
- previous treatment with androgen deprivation therapy for \<90 days and/or recommended but not yet started new line of androgen deprivation therapy
- documented evidence of metastatic disease (bone only; less than 4 lesions contained within the vertebral column or pelvis)
- HV-mHSPC cohort
- previous treatment with androgen deprivation therapy for \<90 days and/or recommended but not yet started new line of androgen deprivation therapy
- documented evidence of "high volume" metastatic disease (visceral metastases \[extranodal\] and/or bone metastases \[\>=4 bone lesions with \>=1 lesion outside the vertebral column or pelvis\])
- mCRPC cohort
- documented evidence of progression while receiving androgen ablation therapy (medical or surgical castration) according to PCWG2 criteria
- documented evidence of metastatic disease (bone or visceral)
- Exclusion Criteria:
- patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer (all cohorts)
- documented evidence of metastatic disease (HR-HSPC cohort)
- documented evidence of castrate-resistance (all HSPC cohorts)
- currently on active androgen deprivation therapy (all HSPC cohorts)
Exclusion
Key Trial Info
Start Date :
June 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04021394
Start Date
June 5 2019
End Date
December 1 2022
Last Update
April 4 2023
Active Locations (1)
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1
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9