Clinical trial · Interventional
Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy
Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study
NCT04848909CI-TRIAL-00089754PLUTO-MPCactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Men with prostate cancer post-prostatectomy
- description
- Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
- interventionNames
- Radiation: stereotactic body radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Early Adverse Events/toxicities experience by Participants
- timeFrame
- 6.5 years
- description
- Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Secondary outcomes (5)
- measure
- Late Adverse Events/toxicities experienced by Participants
- timeFrame
- 6.5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy * Completed written informed consent * Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires * A detectable PSA ≤ 2.0 ng/ml * Two consecutive rises in PSA and final PSA \> 0.1 ng/ml OR three or more consecutive rises in PSA Exclusion Criteria: * Gross residual disease (per conventional imaging, i.e. CT and/or MRI) * Histological or radiological node +ve (N1) or distant metastases (M1) * Prior pelvic radiotherapy * Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
References
Publications (0)
Data not yet available
No reference posted for this study.