Clinical trial · Observational
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
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Acute GU adverse events
- timeFrame
- at the end of treatment and 3 months after the end of treatment
- description
- Acute GU adverse events will be reported as clinician-reported outcomes (according to CTCAE scoring criteria)
- measure
- Acute GI adverse events
- timeFrame
- at the end of treatment and 3 months after the end of treatment
- description
- Acute GI adverse events will be reported as clinician-reported outcomes (according to CTCAE scoring criteria)
- measure
- questionnaire IIEF-5
- timeFrame
- At the baseline and from the end of radiotherapy through study completion, every three months.
- description
- The patient fills out the questionnaire IIEF-5
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Evidence of distant metastasis at the restaging imaging * Patients with current concomitant anticoagulant therapy (antiplatelet therapy is allowed even if it will be temporary suspended before fiducials implant) * Platelets count \< 75'000/uL * Urethral stricture * Having received previous different salvage treatments for PCa local relapse * Development of BCR while on ADT * Concomitant inflammatory bowel disease or other serious systemic comorbidities * Presence of hip prosthesis * Impossibility of performing an MRI
References
Publications (0)
Data not yet available