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

RecruitingNAAges 18 Years - anyMaleJules Bordet Institute
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
INCLUSION CRITERIA 1. Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent. 2. Either persistent PSA after prostatectomy (PSA โ‰ฅ 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 โ‰ฅ18 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.
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What it tests

  • Stereotactic body radiotherapy (SBRT)
  • SOC RT
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Where

13 sites
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
UZ Gent
Ghent, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
AZ Groeninge
Kortrijk, Belgium

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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