NCT06834152Recruiting
Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland, Germany
- Sponsor
- University of Zurich(Other)
- Protocol no.
- RAO-24-014
- Conditions
- Localized Prostate Carcinoma, Prostate Cancer (Adenocarcinoma), Prostate Hyperplasia, Lower Urinary Track Symptoms
- Interventions
- Radiation
Treatments studied
- radiotherapy
Locations · 1
- Zurich, SwitzerlandUniversity Hospital Zurich, Department of Radio-OncologyRecruiting at this site
In total, worldwide, 1 of the 3 sites listed in the registry is recruiting; the other 2 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: July 6, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.