Clinical trial · Interventional
Adaptive MR-guided SBRT for Localized Prostate Cancer
Feasibility Trial of Individualized Daily Dose Adaptation for Localized Prostate Cancer by Online MR-guided SBRT
NCT04571762CI-TRIAL-00077399unknownN/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)
The purpose of this study is to evaluate a technical feasibility of MR-guided SBRT fraction dose adaptation for low-risk, intermediate-risk and low-volume metastatic prostate cancer. .
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 Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Patients with low-risk, intermediate-risk and low-volume metastatic prostate cancer eligible for stereotactic body radiotherapy will be recruited.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
Primary outcomes (1)
- measure
- Feasibility of online MR-guided SBRT: Number of fractions
- timeFrame
- At the treatment end (treatment duration 2 weeks)
- description
- Number of fractions when a new online plan on the new patient geometry was successfully generated and applied according to the dosimetric protocol requirements
Secondary outcomes (5)
- measure
- Rates of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent according to Swiss law and ICH/GCP regulations before any trial specific procedures; * Males; * Histologically confirmed adenocarcinoma of the prostate; * Low (Grade group 1 \[Gleason score ≤6\], clinical stage T1-2a N0 M0, and PSA \< 10 ng/ml) and intermediate (Grade group 2-3 \[Gleason score 7\], clinical stage T2b-2c N0 M0, PSA 10-20 ng/ml) risk prostate cancer with indications for SBRT with curative intent; * Newly diagnosed low-volume metastatic prostate cancer with indications for SBRT, in whom metastatic disease was confirmed on a bone scintigraphic scan and soft-tissue imaging done within 3 months of starting androgen deprivation therapy (ADT); * IPSS \<15; * Age: ≥ 18 years old; * Karnofsky performance status ≥70; * Patients able to tolerate long (approximately 60 minutes) treatment time; * Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures. Exclusion Criteria: * Previous radical treatment for prostate cancer - either radiation therapy (external or brachytherapy), surgery, TUR-P, cryosurgery, or HIFU; * Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia; * Lack of safe contraception; * Known or suspected non-compliance, drug or alcohol abuse; * Inability to follow the procedures of the trial, e.g. due to language problems of the participant; * Enrolment of the investigator, his/her family members, employees and other dependent persons.
References
Publications (0)
Data not yet available
No reference posted for this study.