This is a a randomized phase II/III trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.
This is a multicentric randomized seamless phase II/III study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed. All subjects will be randomly assigned in a 1:1 ratio: 1. Experimental arm: Radiotherapy treatment in 5 fractions. 2. Control arm: Radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. For the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
284
5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.
Standard salvage radiotherapy to the prostate bed with or without whole pelvic radiotherapy. Each participating centre can specify upfront which RT schedule will be used in the control arm, with the choice between the following schedules: * Hypofractionated: 20 fractions (Daily treatment (OTT 4-5 weeks)) * Normofractionated: 32-35 fractions (Daily treatment (OTT 7-8 weeks))
AZorg
Aalst, Belgium
RECRUITINGGZA Ziekenhuis ZAS Kempenstraat
Antwerp, Belgium
RECRUITINGSBRT impact on patient-reported GI and GU symptoms
Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).
Time frame: 2 years post treatment
Patient Reported Outcomes
Patient-reported outcomes according to the different * EPIC-26 domains (0-100) * IPSS score (0-35) * EQ-5D-5L scores (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)
Time frame: at end of RT and following time-points counted from start of RT : 4-7 weeks (only in experimental arm), 3 months, 6 months, 1 year and yearly up to 5 years
Ccost-utility during radiotherapy
Cost-utility analysis based on EQ-5D-5L (five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)versus costs of RT and transportation during radiotherapy
Time frame: during radiotherapy
Physician-scored toxicity
Physician-scored toxicity according to CTCAE 5.0 (grades) (Early: within 90 days; or late: 90 or more days after SBRT). Proportion of patients with G2+ toxicity will be reported specifically.
Time frame: up to 5 years
Blood lymphocyte evolution between study arms
Lymphocyte count nadir relative to baseline
Time frame: 5 years
To compare biochemical progression-free survival (bPFS) to historical control and between study arms
Biochemical progression-free survival (bPFS)
Time frame: 5 years
To compare local and regional recurrences between study arms, up to 5 years.
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Ziekenhuis Aan de Stroom (ZAS)
Antwerp, Belgium
AZ Sint Jan
Bruges, Belgium
RECRUITINGJules Bordet Institute, H.U.B
Brussels, Belgium
RECRUITINGZiekenhuis Oost-Limburg (ZOL) Campus Sint-Jan
Genk, Belgium
RECRUITINGJessa Ziekenhuis
Hasselt, Belgium
RECRUITINGAZ Groeninge
Kortrijk, Belgium
RECRUITINGCHU HELORA - Hôpital de La Louvière - site Jolimont
La Louvière, Belgium
RECRUITINGAZ Sint-Maarten
Mechelen, Belgium
RECRUITING...and 2 more locations
Local and regional control
Time frame: 5 years
To compare Overall survival (OS) between study arms, up to 5 years.
Overall survival (OS)
Time frame: 5 years
To compare distant metastases-free survival (dmFS) between study arms
Distant metastases-free survival (dmFS).
Time frame: 5 years