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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: SOC RT; Radiation: Stereotactic body radiotherapy (SBRT)

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 Type: Interventional
• Enrollment (Estimated): 284
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robbe Van den Begin, MD, PhD; Phone Number: +3225413832; Email: robbe.vandenbegin@hubruxelles.be

Study Locations

• Belgium
  • Aalst, Belgium
    • Recruiting
    • Azorg
    • Contact: Benedikt Engels, MD PhD; Phone Number: 053 72 86 66; Email: radiotherapie@azorg.be
  • Antwerp, Belgium
    • Recruiting
    • Ziekenhuis Aan de Stroom (ZAS)
    • Contact: Piet Dirix, MD PhD; Phone Number: 03 443 37 37; Email: gza.iridiumnetwerk@zas.be
  • Bruges, Belgium
    • Recruiting
    • AZ Sint Jan
    • Contact: Sabine Meersschout, MD; Phone Number: +3250 45 28 00; Email: radiotherapie.brugge@azsintjan.be
  • Brussels, Belgium
    • Recruiting
    • Jules Bordet Institute, H.U.B
    • Contact: Nicolas Jullian, MD; Phone Number: +3225413832
  • Genk, Belgium
    • Recruiting
    • Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan
    • Contact: Laura Vandenbergh, MD; Phone Number: +32 89 80 83 30; Email: info@zol.be
  • Ghent, Belgium
    • Recruiting
    • UZ Gent
    • Contact: Ben Vanneste, MD PhD; Phone Number: +32 9 332 30 15
  • Hasselt, Belgium
    • Recruiting
    • Jessa Ziekenhuis
    • Contact: Philippe Bulens, MD; Phone Number: 011 33 79 79; Email: info@jessazh.be
  • Kortrijk, Belgium
    • Recruiting
    • AZ Groeninge
    • Contact: Nora Sundahl, MD PhD; Phone Number: +3256 63 39 03; Email: radiotherapie@azgroeninge.be
  • La Louvière, Belgium
    • Recruiting
    • CHU HELORA - Hôpital de la Louvière - Site Jolimont
    • Contact: Samuel Palumbo, MD; Phone Number: 064 23 41 88; Email: info@helora.be
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Contact: Charlien Berghen, MD, PhD; Email: radiotherapie@uzleuven.be
  • Mechelen, Belgium
    • Recruiting
    • AZ Sint-Maarten
    • Contact: Cédric Draulans, MD; Phone Number: 015 89 29 80; Email: azsintmaarten@emmaus.be
  • Namur, Belgium
    • Recruiting
    • CHU UCL Namur - Site Elisabeth
    • Contact: Paul Nguyen, MD; Phone Number: +32 (0)81 72 05 25; Email: sormn.se@chuuclnamur.uclouvain.be
  • Woluwe-Saint-Lambert, Belgium
    • Recruiting
    • Cliniques universitaires Saint-Luc (UCLouvain)
    • Contact: Ad Vandermeulen, MD; Phone Number: +32 2 764 47 52; Email: contact-patient@saintluc.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA

1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
2. Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA >0.1 ng/mL , or three consecutive PSA rises)
3. WHO PS 0-1
4. Age ≥18 years
5. Ability to understand and willingness to sign a study-specific informed consent prior to study entry
6. Ability to understand and answer the EPIC-26 form in one of the languages available

EXCLUSION CRITERIA

1. Patients with a pT4 tumor at prostatectomy
2. Patients with previously pathologically confirmed N1
3. Patients with macroscopically involved margin at surgery (R2)
4. Patients with a history of distant metastases
5. Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter >1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence.
6. Latest PSA > 2ng/ml
7. Patients with a IPSS >20
8. Gleason 10 tumor
9. Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate
10. Prior pelvic radiotherapy
11. Prior hormonal therapy started more than 6 weeks before randomization
12. History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.
13. Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT; SBRT: 5 fractions	Radiation: Stereotactic body radiotherapy (SBRT); 5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.
Active Comparator: Control; Standard of care radiotherapy	Radiation: SOC RT; 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))

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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.	up to 5 years
Blood lymphocyte evolution between study arms	Lymphocyte count nadir relative to baseline	5 years
To compare biochemical progression-free survival (bPFS) to historical control and between study arms	Biochemical progression-free survival (bPFS)	5 years
To compare local and regional recurrences between study arms, up to 5 years.	Local and regional control	5 years
To compare Overall survival (OS) between study arms, up to 5 years.	Overall survival (OS)	5 years
To compare distant metastases-free survival (dmFS) between study arms	Distant metastases-free survival (dmFS).	5 years

Collaborators and Investigators

• Sponsor: Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2032

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: CE3764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No