Acinar cell prostatic carcinoma
Conditions
Brief summary
• To determinate if there is improvement in biochemical Disease free survival (bDFS, defined as PSA elevation ≥ 2 ng/ml over Nadir, following the Phoenix criteria*) in patients treated with prostate SBRT + ADT (ARM A) compared to patients treated with SBRT alone (ARM B).
Detailed description
• Disease free survival (DFS, defined as evidence of biochemical, local, regional or distant relapse on imaging)., • Freedom from local recurrence (FFLR, defined as evidence of in-field recurrence detected at imaging and/or Histologically proved), • Freedom from regional recurrence (FFRR, defined as evidence of out-of field recurrence in the true pelvis as defined by TNM VIII criteria for regional node), • Freedom from distant metastasis (FFDM, defined as evidence of out of field recurrence that meets the criteria of M1 defined by TNM VIII), • Overall Survival (OS, defined as death for any cause)
Interventions
DRUGDECAPEPTYL 22
DRUG5 mg / 2ml - Polvere e solvente per sospensione iniettabile a rilascio prolungato
DRUGCasodex 50 mg comprimate filmate
Sponsors
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To determinate if there is improvement in biochemical Disease free survival (bDFS, defined as PSA elevation ≥ 2 ng/ml over Nadir, following the Phoenix criteria*) in patients treated with prostate SBRT + ADT (ARM A) compared to patients treated with SBRT alone (ARM B). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Disease free survival (DFS, defined as evidence of biochemical, local, regional or distant relapse on imaging)., • Freedom from local recurrence (FFLR, defined as evidence of in-field recurrence detected at imaging and/or Histologically proved), • Freedom from regional recurrence (FFRR, defined as evidence of out-of field recurrence in the true pelvis as defined by TNM VIII criteria for regional node), • Freedom from distant metastasis (FFDM, defined as evidence of out of field recurrence that meets the criteria of M1 defined by TNM VIII), • Overall Survival (OS, defined as death for any cause) | — |
Countries
Italy
Outcome results
None listed