Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)

Launched by UNIVERSITY OF ZURICH · Feb 13, 2025

Keywords

ClinConnect Summary

The X-SMILE trial is a clinical study looking at a new way to treat localized prostate cancer using a method called stereotactic body radiotherapy (SBRT). This study aims to see if this treatment is safe and effective for men who have just been diagnosed with prostate cancer and are experiencing lower urinary tract symptoms or prostate enlargement. Participants in this trial will receive targeted radiation therapy over five weeks, which means they will have five treatments where the doctor focuses the radiation on the prostate area to minimize damage to surrounding tissues.

To be eligible for this trial, participants need to have confirmed localized prostate cancer and should not have other severe prostate conditions or previous radiation treatments that could interfere with the study. The trial is looking for men aged 65 to 74 who have specific characteristics of their cancer, such as certain risk levels and prostate size. Those who join the study can expect close monitoring and care throughout the treatment process, helping researchers understand the benefits and safety of this new approach.

Gender

MALE

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.