Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06523634

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

Led by Jules Bordet Institute · Updated on 2026-05-12

284

Participants Needed

13

Research Sites

372 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

AZorg

Aalst, Belgium

Actively Recruiting

2

Ziekenhuis Aan de Stroom (ZAS)

Antwerp, Belgium

Actively Recruiting

3

AZ Sint Jan

Bruges, Belgium

Actively Recruiting

4

Jules Bordet Institute, H.U.B

Brussels, Belgium

Actively Recruiting

5

Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan

Genk, Belgium

Actively Recruiting

6

UZ Gent

Ghent, Belgium

Actively Recruiting

7

Jessa Ziekenhuis

Hasselt, Belgium

Actively Recruiting

8

AZ Groeninge

Kortrijk, Belgium

Actively Recruiting

9

CHU HELORA - Hôpital de La Louvière - site Jolimont

La Louvière, Belgium

Actively Recruiting

10

UZ Leuven

Leuven, Belgium

Actively Recruiting

11

AZ Sint-Maarten

Mechelen, Belgium

Actively Recruiting

12

CHU UCL Namur - Site Elisabeth

Namur, Belgium

Actively Recruiting

13

Cliniques universitaires Saint-Luc (UCLouvain)

Woluwe-Saint-Lambert, Belgium

Actively Recruiting

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Research Team

R

Robbe Van den Begin, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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