Prostate CancerSTEREOBEDNCT06523634
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
A study testing Stereotactic body radiotherapy (SBRT) and SOC RT in people with Prostate Cancer, run by Jules Bordet Institute at 13 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic body radiotherapy (SBRT) and SOC RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 13 sitesBelgium
- Study dates
- 10 Dec 2024to 1 Feb 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
- 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)
- WHO PS 0-1
- Age ≥18 years
- Ability to understand and willingness to sign a study-specific informed consent prior to study entry
- Ability to understand and answer the EPIC-26 form in one of the languages available
Who cannot join
- Patients with a pT4 tumor at prostatectomy
- Patients with previously pathologically confirmed N1
- Patients with macroscopically involved margin at surgery (R2)
- Patients with a history of distant metastases
- 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.
- Latest PSA > 2ng/ml
Show all 13Show fewer
- Patients with a IPSS >20
- Gleason 10 tumor
- Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate
- Prior pelvic radiotherapy
- Prior hormonal therapy started more than 6 weeks before randomization
- History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Belgium13 sites, 13 recruiting
- Recruiting
AZorg
Aalst
Benedikt Engels, MD PhD, 053 72 86 66, radiotherapie@azorg.be
- Recruiting
Ziekenhuis Aan de Stroom (ZAS)
Antwerp
Piet Dirix, MD PhD, 03 443 37 37, gza.iridiumnetwerk@zas.be
- Recruiting
AZ Sint Jan
Bruges
Sabine Meersschout, MD, +3250 45 28 00, radiotherapie.brugge@azsintjan.be
- Recruiting
Jules Bordet Institute, H.U.B
Brussels
Nicolas Jullian, MD, +3225413832
- Recruiting
Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan
Genk
Laura Vandenbergh, MD, +32 89 80 83 30, info@zol.be
- Recruiting
UZ Gent
Ghent
Ben Vanneste, MD PhD, +32 9 332 30 15
- Recruiting
Jessa Ziekenhuis
Hasselt
Philippe Bulens, MD, 011 33 79 79, info@jessazh.be
- Recruiting
AZ Groeninge
Kortrijk
Nora Sundahl, MD PhD, +3256 63 39 03, radiotherapie@azgroeninge.be
- Recruiting
CHU HELORA - Hôpital de La Louvière - site Jolimont
La Louvière
Samuel Palumbo, MD, 064 23 41 88, info@helora.be
- Recruiting
UZ Leuven
Leuven
Charlien Berghen, MD, PhD, radiotherapie@uzleuven.be
- Recruiting
AZ Sint-Maarten
Mechelen
Cédric Draulans, MD, 015 89 29 80, azsintmaarten@emmaus.be
- Recruiting
CHU UCL Namur - Site Elisabeth
Namur
Paul Nguyen, MD, +32 (0)81 72 05 25, sormn.se@chuuclnamur.uclouvain.be
- Recruiting
Cliniques universitaires Saint-Luc (UCLouvain)
Woluwe-Saint-Lambert
Ad Vandermeulen, MD, +32 2 764 47 52, contact-patient@saintluc.uclouvain.be
About this study
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.
Read the 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:
- Experimental arm: Radiotherapy treatment in 5 fractions.
- 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).
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic body radiotherapy (SBRT), SOC RT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy (SBRT)Radiation
5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.
SOC RTRadiation
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))
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard of care radiotherapy Receives: Radiation: SOC RT |
| SBRT | Experimental | SBRT: 5 fractions Receives: Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBRT impact on patient-reported GI and GU symptoms
Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).
Measured: 2 years post treatment
Secondary outcomes (8)
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)
Measured: 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
Measured: 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.
Measured: up to 5 years
Blood lymphocyte evolution between study arms
Lymphocyte count nadir relative to baseline
Measured: 5 years
To compare biochemical progression-free survival (bPFS) to historical control and between study arms
Biochemical progression-free survival (bPFS)
Measured: 5 years
To compare local and regional recurrences between study arms, up to 5 years.
Local and regional control
Measured: 5 years
To compare Overall survival (OS) between study arms, up to 5 years.
Overall survival (OS)
Measured: 5 years
To compare distant metastases-free survival (dmFS) between study arms
Distant metastases-free survival (dmFS).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start10 Dec 2024
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523634
- Sponsor's protocol ID
- CE3764
- Acronym
- STEREOBED
- Status last verified
- Jan 2026
- First submitted
- 28 May 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.
- ClinicalTrials.gov ID
- NCT06523634
- Acronym / sponsor ID
- STEREOBED / CE3764
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Experimental arm: Radiotherapy treatment in 5 fractions.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Radiation: SOC RTStandard of care radiotherapy |
| SBRT | Experimental | Radiation: Stereotactic body radiotherapy (SBRT)SBRT: 5 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
- 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)
- WHO PS 0-1
- Age ≥18 years
- Ability to understand and willingness to sign a study-specific informed consent prior to study entry
Key exclusion criteria (13 listed)
- Patients with a pT4 tumor at prostatectomy
- Patients with previously pathologically confirmed N1
- Patients with macroscopically involved margin at surgery (R2)
- Patients with a history of distant metastases
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapy (SBRT)5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day. | Radiation | SBRT |
| SOC RTStandard 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)) | Radiation | Control |
Primary outcome
SBRT impact on patient-reported GI and GU symptoms
Time frame: 2 years post treatment
Urinary and bowel domain of the EPIC-26 (Expanded Prostate Cancer Index Composite).
8 secondary outcomes
Patient Reported Outcomes
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
Time frame: during radiotherapy
Physician-scored toxicity
Time frame: up to 5 years
Blood lymphocyte evolution between study arms
Time frame: 5 years
To compare biochemical progression-free survival (bPFS) to historical control and between study arms
Time frame: 5 years
To compare local and regional recurrences between study arms, up to 5 years.
Time frame: 5 years
To compare Overall survival (OS) between study arms, up to 5 years.
Time frame: 5 years
To compare distant metastases-free survival (dmFS) between study arms
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiotherapy (SBRT) and SOC RT in people with Prostate Cancer, run by Jules Bordet Institute at 13 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robbe Van den Begin, MD, PhD (+3225413832, robbe.vandenbegin@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SBRT impact on patient-reported GI and GU symptoms (time frame: 2 years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.