Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer

Recruiting now

Conditions studied: Localized Prostate Carcinoma, Prostate Cancer (Adenocarcinoma), Prostate Hyperplasia, Lower Urinary Track Symptoms

In brief

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.

Key facts

Study ID

NCT06834152

Run by

University of Zurich

People needed

75

Starts

2024-03-01

Expected to finish

2031-06-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• University Hospital Zurich, Department of Radio-Oncology — Zurich, Canton of Zurich, Switzerland (enrolling)
• Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
• Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMU — Munich, Bavaria, Germany

Full record on ClinicalTrials.gov

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