RecruitingNot ApplicableNCT06523634

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


Sponsor

Jules Bordet Institute

Enrollment

284 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to radiation therapy for men whose prostate cancer has returned after prostate removal surgery (radical prostatectomy). The standard approach delivers many small doses of radiation over several weeks; the study approach (stereotactic body radiotherapy, or SBRT) delivers fewer, larger doses over a shorter time. Researchers want to see if the shorter course is just as effective with fewer side effects. **You may be eligible if...** - You had prostate cancer treated with prostate removal surgery (radical prostatectomy) - Your PSA (a prostate cancer marker in the blood) is rising after surgery, suggesting the cancer may have returned in the prostate area - You are 18 or older with good overall health (WHO performance status 0–1) - Your latest PSA is 2 ng/mL or below - You have no signs of cancer spread beyond the prostate area on imaging **You may NOT be eligible if...** - Your cancer spread to lymph nodes or has distant metastases - You have had prior radiation to the pelvis - Your prostate cancer is the highest-grade (Gleason 10) type - You have inflammatory bowel disease or certain other pelvic conditions - You have already received hormone therapy for more than 6 weeks before this trial - Your urinary symptoms score is very high (IPSS > 20) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic body radiotherapy (SBRT)

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

RADIATIONSOC 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))


Locations(12)

AZorg

Aalst, Belgium

Ziekenhuis Aan de Stroom (ZAS)

Antwerp, Belgium

AZ Sint Jan

Bruges, Belgium

Jules Bordet Institute, H.U.B

Brussels, Belgium

Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan

Genk, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

CHU HELORA - Hôpital de La Louvière - site Jolimont

La Louvière, Belgium

UZ Leuven

Leuven, Belgium

AZ Sint-Maarten

Mechelen, Belgium

CHU UCL Namur - Site Elisabeth

Namur, Belgium

Cliniques universitaires Saint-Luc (UCLouvain)

Woluwe-Saint-Lambert, Belgium

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NCT06523634


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