Adaptive radiotherapy for localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international multicenter study evaluates the safety, feasibility, and efficacy of online adaptive stereotactic body radiotherapy (SBRT) for patients with newly diagnosed localized prostate cancer who also experience lower urinary tract symptoms or prostatic hyperplasia. The treatment involves delivering SBRT in five weekly fractions, guided by either CT or MRI imaging. The primary goal is to assess the rate of urogenital toxicity within three months post-treatment, aiming to demonstrate that this rate remains below a clinically acceptable threshold. The study targets patients with intermediate to very high-risk localized prostate cancer, focusing on those with specific symptom scores and prostate volume criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital Zurich, Department of Radio-Oncology
  Zurich, Canton of Zurich, Switzerland Recruiting
• Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Heidelberg
  Heidelberg, Baden-Wurttemberg, Germany Not yet recruiting
• Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum LMU
  Munich, Bavaria, Germany Not yet recruiting

Study contacts

• Principal investigator: Tiuri E. Kroese, MD, PhD — University of Zurich
• Study coordinator: Radiation Oncology Study Office
• Email: RAO_akademischesoffice@usz.ch
• Phone: +41442554108

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.