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

NCT ID: NCT06523634

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2032-02-01

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard of care radiotherapy

Group Type: ACTIVE_COMPARATOR

SOC RT

Intervention Type: RADIATION

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))

SBRT

SBRT: 5 fractions

Group Type: EXPERIMENTAL

Stereotactic body radiotherapy (SBRT)

Intervention Type: RADIATION

5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.

Interventions

Stereotactic body radiotherapy (SBRT)

5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.

Intervention Type: 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))

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZorg

Aalst, , Belgium

Site Status: RECRUITING

GZA Ziekenhuis ZAS Kempenstraat

Antwerp, , Belgium

Site Status: RECRUITING

Ziekenhuis Aan de Stroom (ZAS)

Antwerp, , Belgium

Site Status: RECRUITING

AZ Sint Jan

Bruges, , Belgium

Site Status: RECRUITING

Jules Bordet Institute, H.U.B

Brussels, , Belgium

Site Status: RECRUITING

Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan

Genk, , Belgium

Site Status: RECRUITING

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status: RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status: RECRUITING

CHU HELORA - Hôpital de La Louvière - site Jolimont

La Louvière, , Belgium

Site Status: RECRUITING

AZ Sint-Maarten

Mechelen, , Belgium

Site Status: RECRUITING

CHU UCL Namur - Site Elisabeth

Namur, , Belgium

Site Status: RECRUITING

Cliniques universitaires Saint-Luc (UCLouvain)

Woluwe-Saint-Lambert, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Robbe Van den Begin, MD, PhD

Role: CONTACT

robbe.vandenbegin@hubruxelles.be

+3225413832

Facility Contacts

Benedikt Engels, MD PhD

Role: primary

radiotherapie@azorg.be

053 72 86 66

Piet Dirix

Role: primary

Piet Dirix, MD PhD

Role: primary

gza.iridiumnetwerk@zas.be

03 443 37 37

Sabine Meersschout, MD

Role: primary

radiotherapie.brugge@azsintjan.be

+3250 45 28 00

Nicolas Jullian, MD

Role: primary

+3225413832

Laura Vandenbergh, MD

Role: primary

info@zol.be

+32 89 80 83 30

Philippe Bulens, MD

Role: primary

info@jessazh.be

011 33 79 79

Nora Sundahl, MD PhD

Role: primary

radiotherapie@azgroeninge.be

+3256 63 39 03

Samuel Palumbo, MD

Role: primary

info@helora.be

064 23 41 88

Cédric Draulans, MD

Role: primary

azsintmaarten@emmaus.be

015 89 29 80

Paul Nguyen, MD

Role: primary

sormn.se@chuuclnamur.uclouvain.be

+32 (0)81 72 05 25

Ad Vandermeulen, MD

Role: primary

contact-patient@saintluc.uclouvain.be

+32 2 764 47 52

Other Identifiers

CE3764

Identifier Type: -

Identifier Source: org_study_id