Approval Probability
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Adjusted LOA
ML Risk
SBRT+ Durvalumab · 1 trial · 3 indications
The primary outcome will be progression-free survival, defined as the time from randomization until a biochemical-clinical failure
| Arm | Type | Description |
|---|---|---|
| Arm SBRT + DURVALUMAB | EXPERIMENTAL | Radiation (SBRT) + Immunotherapy treatment (Durvalumab) 64 patients will be enrolled in this arm Durvalumab, will be started one month prior to SBRT and then given for a total of 12 months. Patient will receive one injection per months (1500 mg/cycle) SBRT will be started one month after Durvalumab and patients will receive 3 fractions of radiation |
| Arm SBRT | ACTIVE_COMPARATOR | Radiation (SBRT) 32 patients will be enrolled in this arm Patients will receive only 3 fractions of radiation |
| Name | Type | Description |
|---|---|---|
| SBRT + Durvalumab | COMBINATION_PRODUCT | Durvalumab, MEDI4736, is a immunotherapy, SBRT (stereotactic body radiotherapy) is a procedure that uses high doses of radiation delivered to a precise target. By using special positioning and implanted markers in the body, radiologists are able to deliver a much higher dose of radiation to a cancer than traditional radiation therapy |
| SBRT | RADIATION | SBRT (stereotactic body radiotherapy) is a procedure that uses high doses of radiation delivered to a precise target. By using special positioning and implanted markers in the body, radiologists are able to deliver a much higher dose of radiation to a cancer than traditional radiation therapy |
Inclusion Criteria: 1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations 2. Age \> or = 18 years at time of study entry 3. Histologically proven diagnosis of prostate cancer (PCa) 4. PCa patients with a biochemica...
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