Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alessia Farneti | UNKNOWN |
| Adriana Faiella | UNKNOWN |
| Marta Bottero | UNKNOWN |
| Pasqualina D'Urso |
Not provided
Not provided
Not provided
Not provided
After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients.
The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.
The present study aims at delivering 30 Gy to the prostatic bed in 5 fractions. At the same time, the pelvic nodes will be covered to 25 Gy, but in those patients considered at low risk of nodal involvement. In patients with evidence of macroscopic disease at the tumor bed through DCE-MRI, 40 Gy will be delivered in 5 fractions.
Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm, non randomized | Experimental | SBRT 30 Gy/ 5 fractions |
|
| radiation, SBRT | Experimental | SBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salvage SBRT | Radiation | steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-yr BFFS | The primary objective of the study is 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after RP | 3-years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-y OS | The secondary objective is 3-yr overal survival | 3-years |
| 3-y LC | The secondary objective is 3-yr locoregional control assessed with PSA |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Sanguineti, Professor | Contact | 0652663015 | giuseppe.sanguineti@ifo.it | |
| Paola Franzoso, DM | Contact | 0652666125 | paola.franzoso@ifo.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina Elena National Cancer Institute | Recruiting | Rome | 00144 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| Valeria Landoni | UNKNOWN |
| Antonella Soriani | UNKNOWN |
| Luca Bertini | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| 3-years |
| 3-y MFS | The secondary objective is 3-yr metastases free survival | 3-years |
| 3-y GU GI tox | The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0 | 3-years |
| 3-y QoL | The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD) | 3-years |
| 3-y - Patient satisfaction with treatment | The secondary objective is 3-y patient satisfaction with treatment (FACIT-TS-G) | 3-years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |