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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer
Regina Elena National Cancer Institute
Rome, Italy
RECRUITING3-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
Time frame: 3-years
3-y OS
The secondary objective is 3-yr overal survival
Time frame: 3-years
3-y LC
The secondary objective is 3-yr locoregional control assessed with PSA
Time frame: 3-years
3-y MFS
The secondary objective is 3-yr metastases free survival
Time frame: 3-years
3-y GU GI tox
The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0
Time frame: 3-years
3-y QoL
The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD)
Time frame: 3-years
3-y - Patient satisfaction with treatment
The secondary objective is 3-y patient satisfaction with treatment (FACIT-TS-G)
Time frame: 3-years
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