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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
AZorg
RECRUITING
Aalst
Ziekenhuis Aan de Stroom (ZAS)
RECRUITING
Antwerp
AZ Sint Jan
RECRUITING
Bruges
Jules Bordet Institute, H.U.B
RECRUITING
Brussels
Jessa Ziekenhuis
RECRUITING
Hasselt
AZ Groeninge
RECRUITING
Kortrijk
CHU HELORA - Hôpital de La Louvière - site Jolimont
NOT_YET_RECRUITING
La Louvière
AZ Sint-Maarten
RECRUITING
Mechelen
CHU UCL Namur - Site Elisabeth
RECRUITING
Namur
Contact Information
Primary
Robbe Van den Begin, MD, PhD
robbe.vandenbegin@hubruxelles.be
+3225413832
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2032-02-01
Participants
Target number of participants: 284
Treatments
Active_comparator: Control
Standard of care radiotherapy
Experimental: SBRT
SBRT: 5 fractions
Related Therapeutic Areas
Sponsors
Leads: Jules Bordet Institute

This content was sourced from clinicaltrials.gov

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