Radiotherapy for prostate cancer recurrence after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial compares salvage stereotactic body radiotherapy (SBRT) with standard of care (SOC) regimens for patients experiencing biochemical recurrence of prostate cancer following radical prostatectomy. It is a multicentric randomized study where participants are assigned to either receive SBRT in five fractions or conventional radiotherapy in a normofractionated or mildly hypofractionated schedule. The goal is to evaluate the effectiveness of SBRT in managing persistent detectable PSA levels or biochemical progression in these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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
• UZ Gent
  Ghent, Belgium Recruiting

Study contacts

• Study coordinator: Robbe Van den Begin, MD, PhD
• Email: robbe.vandenbegin@hubruxelles.be
• Phone: +3225413832

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.