Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: SOC RT; Radiation: stereotactic body radiotherapy

• Registration Number: NCT06523634
• Lead Sponsor: Jules Bordet Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-26
• Status Verified: 2024-12
• Study Start: 2024-12-10
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Primary Completion: 2029-02-01
• Study Completion: 2032-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 284

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	SOC RT	Hypofractionated regimen
SBRT	stereotactic body radiotherapy	SBRT: 5 fractions

Primary Outcome Measures

Name	Time	Method
SBRT impact on patient-reported GI and GU symptoms	2 years post treatment	Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).

Secondary Outcome Measures

Name	Time	Method
To compare distant metastases-free survival (dmFS) between study arms	5 years	Distant metastases-free survival (dmFS).
Blood lymphocyte evolution between study arms	5 years	Lymphocyte count nadir relative to baseline
Physician-scored toxicity	up to 5 years	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.
Patient Reported Outcomes	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	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)
Ccost-utility during radiotherapy	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
To compare biochemical progression-free survival (bPFS) to historical control and between study arms	5 years	Biochemical progression-free survival (bPFS)
To compare local and regional recurrences between study arms, up to 5 years.	5 years	Local and regional control
To compare Overall survival (OS) between study arms, up to 5 years.	5 years	Overall survival (OS)

Trial Locations

Locations (7)

AZorg; 🇧🇪 Aalst, Belgium

Ziekenhuis Aan de Stroom (ZAS); 🇧🇪 Antwerpen, Belgium

Jules Bordet Institute, H.U.B; 🇧🇪 Brussels, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

CHU HELORA - Hôpital de La Louvière - site Jolimont; 🇧🇪 La Louvière, Belgium

AZ Sint-Maarten; 🇧🇪 Mechelen, Belgium

CHU UCL Namur - Site Elisabeth; 🇧🇪 Namur, Belgium