PSA Response at 10 Months
| Group | Value (Participants) |
|---|---|
| Docetaxel + Degarelix | 15 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.
NCT030699371 Mar 2017 to 11 Dec 2024
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.
Experimental
Docetaxel + Degarelix
Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses.
Outcomes the sponsor listed as primary.
PSA Response at 10 Months
Time frame · 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.
PSA Response at 6 Months
Time frame · 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.
Number of Grade 3 and 4 Adverse Events Related to Docetaxel During First 4 Cycles
Time frame · Up to 12 weeks (first 4 cycles of docetaxel)
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
Frequency of Disease Progression at 12 Weeks Using PSA
Time frame · 12 weeks
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.
PSA Response at 12 Weeks
Time frame · 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 to Development of Castration Resistance After Initiation With ADT
Time frame · From initiation of Degarelix until disease progression or end of follow-up (up to 34 months)
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.
Progression Free Survival
Time frame · 34 months
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.
Overall Survival (OS)
Time frame · From trial enrollment until death or end of follow-up (up to 52.4 months)
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Docetaxel + Degarelix | 15 |
| Group | Value (Participants) |
|---|---|
| Docetaxel + Degarelix | 14 |
| Group | Value (adverse events) |
|---|---|
| Docetaxel + Degarelix | 6 |
| Group | Value (Participants) |
|---|---|
| Docetaxel + Degarelix | 12 |
| Group | Value (Participants) |
|---|---|
| Docetaxel + Degarelix | 1 |
| Group | Value (months) |
|---|---|
| Docetaxel + Degarelix | 16.1 |
| Group | Value (months) |
|---|---|
| Docetaxel + Degarelix | 15.9 |
| Group | Value (months) |
|---|---|
| Docetaxel + Degarelix | 52.4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Docetaxel + DegarelixDocetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg. | 28 / 51 | 4 / 51 | 49 / 51 |
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