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Prostatic Neoplasms

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

SBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes

steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer

salvage SBRT

Giuseppe Sanguineti, Professor

Paola Franzoso, DM

giuseppe sanguineti, Professor

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.

Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study

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

The secondary objective is 3-yr overal survival

The secondary objective is 3-yr locoregional control assessed with PSA

The secondary objective is 3-yr metastases free survival

The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0

The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP	NCT05667636	Prostatic Neopl...	salvage SBRT	18 Years -	Regina Elena Cancer Institute
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP	NCT05667636	Prostatic Neopl...	salvage SBRT	18 Years -	Regina Elena Cancer Institute

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