Table 1.
Definitions of endpoints
| Endpoints | Definitions |
|---|---|
|
| |
| Event-driven endpoints | |
| OS | Time from randomization to the date of death from PC or any other cause |
| MFS | Time from randomization to the date of distant metastases or death from any cause |
| PCSS | Time from randomization to the date of death from PC or complications related to the protocol treatment |
| DFS | Time from randomization to the date of locoregional recurrence, distant metastasis, or death |
| EFS (general definition) | Time from randomization to the date of any event of PSA recurrence, locoregional recurrence, distant metastasis, or death |
| Specific EFS definitions | Specific definitions are based on PSA recurrence defined as follows: |
| EFS (PSA nadir + 2 ng/ml) | PSA nadir + 2 ng/ml |
| EFS (PSA nadir + 2 ng/ml and rising) | PSA nadir + 2 ng/ml and rising |
| EFS (PSADT <3 mo) | PSADT <3 mo |
| EFS (PSADT <6 mo) | PSADT <6 mo |
| EFS (PSADT <9 mo) | PSADT <9 mo |
| EFS (PSA >5 ng/ml) | PSA >5 ng/ml |
| EFS (PSA >10 ng/ml) | PSA >10 ng/ml |
| EFS (PSA >25 ng/ml) | PSA >25 ng/ml |
| BCF (general definition) | Time from randomization to the date of PSA recurrence |
| Specific BCF definitions: | Specific definitions are based on PSA recurrence defined as: |
| BCF (PSA nadir+2 ng/ml) | PSA nadir+2 ng/ml |
| BCF (PSA nadir+2 and rising) | PSA nadir+2 and rising |
| BCF (PSADT <3 mo) | PSADT <3 mo |
| BCF (PSADT <6 mo) | PSADT <6 mo |
| BCF (PSADT <9 mo) | PSADT <9 mo |
| BCF (PSA >5 ng/ml) | PSA >5 ng/ml |
| BCF (PSA >10 ng/ml) | PSA >10 ng/ml |
| BCF (PSA >25 ng/ml) | PSA >25 ng/ml |
| GCF (general definition) | Time from randomization to the date of occurrence of locoregional recurrence, distant metastases, PSA recurrence after completion of radiation therapy, or initiation of ADT after completion of protocol treatment |
| Specific GCF definitions | Specific definitions are based on PSA levels and presencea or absence of ADT initiation or presence of death as an event |
| GCF (PSA >5 ng/ml) | PSA >5 ng/ml |
| GCF (PSA >10 ng/ml) | PSA >10 ng/ml |
| GCF (PSA >25 ng/ml) | PSA >25 ng/ml |
| GCF (PSA >5 ng/ml; no ADT) | PSA >5 ng/ml and ADT initiation is excluded |
| GCF (PSA >10 ng/ml; no ADT) | PSA >10 ng/ml and ADT initiation is excluded |
| GCF (PSA >25 ng/ml; no ADT) | PSA >25 ng/ml and ADT initiation is excluded |
| GCF (PSA >5 ng/ml + death) | PSA >5 ng/ml and death |
| GCF (PSA >10 ng/ml + death) | PSA >10 ng/ml and death |
| GCF (PSA >25 ng/ml + death) | PSA >25 ng/ml and death |
| Binary endpoints | |
| NED | Defined as patients meeting all of the following: 1. Alive 2. No biochemical recurrence (defined as PSA >0.5 ng/ml+nadir and rising) 3. No distant metastasis 4. No loco-regional recurrence 5. No subsequent therapy for PC 6. Testosterone recovery to pre-ADT levels (if available) b |
| EFS (PSADT <6 mo/ADT) | Achievement of an event defined as PSADT of <6 mo (PSADT <6 mo), initiation of ADT, locoregional recurrence, distant metastases, or death due to any cause prior to the landmark time |
| Additional definitions | |
| Locoregional recurrence | More than 50% increase in prostate volume compared with the lowest volume by imaging, detection of a new palpable pelvic lesion in the event of previous complete clinical normalization, identification by biopsy or imaging of a new regional lymph node, or biopsy-proven recurrence within the prostate gland, whichever occurred first |
| PSA recurrence | |
| PSA nadir + 2 ng/ml | PSA 2 ng/ml above nadir |
| PSA nadir + 2 ng/ml and rising | PSA nadir + 2 ng/ml and PSA increases at the next visit |
| PSA >5, >10, or >25 ng/ml | PSA values of >5, >10, or >25 ng/ml after nadir |
| PSADT <6 mo | PSA doubling time of <6 mo |
ADT = androgen-deprivation therapy; BCF = biochemical failure; DFS = disease-free survival; EFS = event-free survival; GCF = general clinical failure; MFS = metastasis-free survival; NED = no evidence of disease; OS = overall survival; PC = prostate cancer; PCSS = PC-specific survival; PSA = prostate-specific antigen; PSADT = PSA doubling time.
If data on ADT initiation were not available, patients were considered negative for the endpoints but were included in the total patient number (denominator).
Patients were considered to have testosterone recovery if their serum testosterone increased to be above the level before ADT initiation. If data on testosterone recovery or initiation of ADT were not available, patients were considered negative for NED if all the other criteria are met but were included in the total number of patients (denominator).