PRospective Observational Study of STereotactic Body rAdiation Therapy With Androgen Depri
Prostate Cancer (PCa) is the second most common malignancy and the 5th common cause of cancer-related mortality in men worldwide. The majority of patients with PCa is diagnosed with potentially curable disease and its management includes different approaches, such as surgery, Radiation Therapy (RT) and Androgen Depriva
| Condition(s) | High Risk Prostate Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Prostate Cancer (PCa) is the second most common malignancy and the 5th common cause of cancer-related mortality in men worldwide. The majority of patients with PCa is diagnosed with potentially curable disease and its management includes different approaches, such as surgery, Radiation Therapy (RT) and Androgen Deprivation Therapy (ADT), for exclusive use or in combination each other. Randomized clinical trials have shown that moderate hypofractionated RT (i.e., 2.5-4 Gy per fraction) has become a valid alternative to conventionally fractionated RT in patients with PCa. The rationale of hypofractionation is based on the strong radiobiological evidence of the low α/β ratio of PCa cells (1.5-2 Gy) and the greater sensitivity to high dose per fraction. Data suggests that prostate Stereotactic |
| Who can participate | Inclusion Criteria: * Age \> 18 years * ECOG performance status ≤ 2 * Histologically proven prostate adenocarcinoma * High-risk group classification according to National Comprehensive Cancer Network (NCCN), defined by the presence of any one of the following high-risk factors: cT3-cT4 OR Grade Group 4 or Grade Group 5 OR PSA \>20 ng/mL * No pelvic nodal and distant metastases at staging with PSMA-PET * IPSS ≤ 15 (alpha blockers allowed) * Life expectancy of \> 5 years * Prostate volume ≤ 100 cc Exclusion Criteria: * Previous local radiation treatment of the prostate * Previous radiotherapy to the pelvis * Active Ulcerative Colitis or Crohn's Disease * Previous tumors unless disease free for a minimum of 5 years |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Istituto Clinico Humanitas |
| Locations | Bergamo, Bergamo, Italy; Milan, Milan, Italy; Rozzano, Milan, Italy |
| Start date | 2025-04-04 |
| NCT ID | NCT06949254 |
| Official listing | https://clinicaltrials.gov/study/NCT06949254 |