The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.
This study will look at two drugs, docetaxel and degarelix, which are both FDA approved for the treatment of prostate cancer. Docetaxel is a standard chemotherapy treatment for metastatic prostate cancer. Degarelix is an androgen deprivation therapy (ADT) agent that decreases the amount of testosterone in the body, which helps to fight tumor growth. Usually, docetaxel is given after ADT. This study will look at how your cancer changes when docetaxel is started before ADT. You are being asked to participate in this study because you have metastatic prostate cancer that can be treated with docetaxel and ADT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Medical University of South Carolina
Charleston, South Carolina, United States
PSA Response at 10 Months
PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least three weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least three weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.
Time frame: 10 months
PSA Response at 6 Months
PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least three weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least three weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.
Time frame: 6 months
Number of Grade 3 and 4 Adverse Events Related to Docetaxel During First 4 Cycles
This measure reports the number of Grade 3 and 4 adverse events that were possibly or probably related to docetaxel and occurred during the first 4 cycles (approximately 12 weeks) of treatment
Time frame: Up to 12 weeks (first 4 cycles of docetaxel)
Frequency of Disease Progression at 12 Weeks Using PSA
PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least two weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir. PSA progression will not be established during the first 12 weeks of therapy (4 cycles of docetaxel) as defined by PCWG2 criteria. Thus subjects with no PSA decline from baseline during therapy will have date of PSA progression defined as first PSA value after 12 weeks that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 weeks
PSA Response at 12 Weeks
PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least two weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA Partial Response is defined as a decline of PSA from trial baseline of \> 50% for two consecutive measurements at least two weeks apart. Date of partial response will be defined as the date of first recorded decline of \> 50% baseline. PSA progression is defined in outcome 4.
Time frame: 12 weeks
Time to Development of Castration Resistance After Initiation With ADT
This will be defined as the time from initial Degarelix injection to the time of disease progression (clinical, radiographic or PSA. Determination of castration resistant disease status will require disease progression and a measured serum testosterone level less than 50 ng/dl.
Time frame: From initiation of Degarelix until disease progression or end of follow-up (up to 34 months)
Progression Free Survival
Progression free Survival (PFS) will be defined as the duration of time from start of study treatment to time of disease progression or death, whichever comes first.
Time frame: 34 months
Overall Survival (OS)
OS is defined as the time interval from trial enrollment to death due to any cause. Survival times will be censored for patients lost to follow-up or still alive at the trial's termination.
Time frame: From trial enrollment until death or end of follow-up (up to 52.4 months)