• Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

  NCT05667636

  Unknown statusInterventionalPhase 2Updated Dec 28, 2022
• Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy

  NCT06201078

  RecruitingInterventionalPhase 2Updated Mar 13, 2025
• Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

  NCT03541850

  Active, not recruitingInterventionalPhase 2Updated Nov 6, 2025
• PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy

  NCT04642027

  RecruitingInterventionalPhase 3Updated Feb 28, 2024
• Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy

  NCT05746806

  Active, not recruitingInterventionalNot ApplicableUpdated Dec 31, 2025
• Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence

  NCT06941363

  RecruitingObservationalUpdated Feb 2, 2026

ClinicalTrials.gov ID

NCT06523634

Lead Sponsor

Jules Bordet InstituteOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

284Estimated

Last Update Posted

May 12, 2026Actual

Start Date

Dec 10, 2024Actual

Primary Completion Date

Feb 1, 2029Estimated

Completion Date

Feb 1, 2032Estimated

Official Title

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

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).

• Prostate Cancer

• Stereotactic body radiotherapy (SBRT)
• SOC RT

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Jules Bordet InstituteOTHER

radiotherapie.brugge@azsintjan.be+3250 45 28 00

+32 9 332 30 15

radiotherapie@azgroeninge.be+3256 63 39 03

radiotherapie@uzleuven.be