This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The choice of the standard of care LHRH analog will be at the discretion of the treating physician.
The choice of the standard of care ARSI will be at the discretion of the treating physician.
Docetaxel will be given by IV infusion at 75mg/m2 once every 3 weeks.
Moffitt Caner Center
Tampa, Florida, United States
Castration Sensitivity Rate
Percentage of patients who remain castration sensitive at 36 months from initiation of LHRH analog for stage IV prostate cancer.
Time frame: Up to 36 months
On treatment PSA Progression Free Survival
On treatment PSA progression free survival will be analyzed using the Kaplan-Meier method.
Time frame: Up to 36 months
Radiographic Progression Free Survival
Radiographic progression free survival will be analyzed using the Kaplan-Meier method.
Time frame: Up to 36 months
Overall Survival
Overall survival will be analyzed using the Kaplan-Meier method.
Time frame: Up to 36 months
Patient Reported Outcome
Patient reported outcome as measured by National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Prostate Cancer Symptom Index -17 items (NFPSI-17).
Time frame: Up to 36 months
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