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

NCT06523634 | Recruiting DMC

• 1 other identifier: CE3764
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 12

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Patient Reported Outcomes

  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

  during radiotherapy

• Physician-scored toxicity

  up to 5 years

• Blood lymphocyte evolution between study arms

  5 years

• To compare biochemical progression-free survival (bPFS) to historical control and between study arms

  5 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard of care radiotherapy

Radiation: SOC RT

SBRT

EXPERIMENTAL

SBRT: 5 fractions

Radiation: Stereotactic body radiotherapy (SBRT)

Interventions

SOC RT 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))

Control

Stereotactic body radiotherapy (SBRT) RADIATION

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

SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (12)

AZorg

Aalst, Belgium

RECRUITING

Ziekenhuis Aan de Stroom (ZAS)

Antwerp, Belgium

RECRUITING

AZ Sint Jan

Bruges, Belgium

RECRUITING

Jules Bordet Institute, H.U.B

Brussels, Belgium

RECRUITING

Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan

Genk, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, Belgium

RECRUITING

AZ Groeninge

Kortrijk, Belgium

RECRUITING

CHU HELORA - Hôpital de La Louvière - site Jolimont

La Louvière, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

AZ Sint-Maarten

Mechelen, Belgium

RECRUITING

CHU UCL Namur - Site Elisabeth

Namur, Belgium

RECRUITING

Cliniques universitaires Saint-Luc (UCLouvain)

Woluwe-Saint-Lambert, Belgium

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Robbe Van den Begin, MD, PhD

CONTACT

+3225413832; robbe.vandenbegin@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-inferiority randomized controlled trial

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: July 26, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2032
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (12)