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NCT07810660Not yet recruiting

RE-irradiation for Isolated FOCal Recurrence of Prostate Cancer With Ultrahypofracted SBRT

RE-irradiation for Isolated FOCal Recurrence of Prostate Cancer With Ultrahypofracted SBRT: The RE-FOCUS Study - Pushing the Boundaries of Precision and Efficacy

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

Prostate cancer (PCa) is one of the most frequently diagnosed malignancies in men worldwide, with the highest prevalence observed in developed countries. Patients affected by localized disease can be treated with several local modalities, including radical prostatectomy (RP), external beam radiotherapy (EBRT) and brachytherapy (BT). Although the advances in treatment strategies, after primary treatment 5 to 60% of men experience biochemical recurrence (BCR).

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
31 Aug 2026
Start date
Sept 2026
Primary completion date
1 May 2030
Lead sponsor
European Institute of Oncology
NCT number
NCT07810660

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From Sept 2026 to the primary completion date, 1 May 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with current concomitant anticoagulant therapy (antiplatelet therapy is allowed even if it will be temporary suspended before fiducials implant)
  • Having received previous different salvage treatments for PCa local relapse
  • Concomitant inflammatory bowel disease or other serious systemic comorbidities

Lab values

  • Platelets count \< 75'000/uL

Other

  • Evidence of distant metastasis at the restaging imaging
  • Urethral stricture
  • Development of BCR while on ADT
  • Presence of hip prosthesis
  • Impossibility of performing an MRI

Who the study is looking for

  • Age \> 18 and \< 80 years
  • Histologically confirmed adenocarcinoma of the prostate initial diagnosis
  • History of a previous adjuvant/salvage RT following prostatectomy or curative RT
  • Diagnosis of local recurrence at the restaging imaging in hormone sensitive patients (maximum 1 prostate bed recurrence and 3 intraprostatic recurrences)
  • DICOM plan of the previous RT course
  • No evidence of greater than grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) or gastrointestinal (GI) late adverse events from the previous RT course
  • Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
  • Good urinary flow (peak flow \>10 mL/s) or IPSS \< 15
  • Written informed consent for treatment and research purpose

Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.