NCT06834152 Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)
| NCT ID | NCT06834152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Localized Prostate Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2024-03-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and/or prostatic hyperplasia.
Eligibility Criteria
Inclusion Criteria: * histologically confirmed localized prostate cancer * planned treatment is SBRT according to standard of care and consists of definitive CT or MRI online adaptive SBRT of the prostate according to the PACE trial which includes a total dose to clinical target volume 1 (CTV1, i.e. prostate and proximal 1 cm of the seminal vesicle) of 40.0 Gy in 5 weekly fractions (single dose of 8.0 Gy) and total dose to planning target volume 1 (PTV1) of 37.5 Gy in 5 weekly fractions (single dose of 7.5 Gy) with a compromise for bowel sparing allowed. For patients with unfavorable intermediate to very high-risk disease (according to NCCN guidelines) a total dose to the planning target volume 2 (PTV2, i.e. proximal 1-2 cm of the seminal vesicle) of 32.5 Gy in 5 weekly fractions (single dose of 6.5 Gy) will be delivered. * intermediate to (very) high risk localized prostate cancer (≤ cT3a and Gleason score ≤ 9 and/or PSA ≤ 20 ng/ml) * prostate volume \> 60 cc and/or IPSS \> 12; Exclusion Criteria: * Very high risk localized prostate cancer with indication for ADT and ARPI (i.e. Gleason ≥ 8 and cT3a) * Involvement of seminal vesicles (cT3b) * Contraindications against definitive CT or MRI-adaptive radiotherapy of the prostate, e.g. inflammatory bowel disease (IBD); previous radiotherapy in the pelvis, previous local radiotherapy of the prostate, contraindication for MRI or CT; * Patients with severe genitourinary symptoms (e.g. recent urinary retention ≥ grade 3 according CTCAE v.5.0); * Lymph node metastases or distant metastases (i.e. no localised prostate cancer); * Participation in a clinical trial which might influence the results of this project.
Contact & Investigator
Matthias Guckenberger, Prof. Dr. med.
STUDY CHAIR
University of Zurich
Frequently Asked Questions
Who can join the NCT06834152 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Localized Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06834152 currently recruiting?
Yes, NCT06834152 is actively recruiting participants. Contact the research team at RAO_akademischesoffice@usz.ch for enrollment information.
Where is the NCT06834152 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Munich, Germany, Zurich, Switzerland.
Who is sponsoring the NCT06834152 clinical trial?
NCT06834152 is sponsored by University of Zurich. The principal investigator is Matthias Guckenberger, Prof. Dr. med. at University of Zurich. The trial plans to enroll 75 participants.