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Weekly Online CT or MR Adaptive Definitive SBRT for Very High Risk Localized or Regionally Metastatic Prostate Cancer

NCT07591051 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-15

No results posted yet for this study

Summary

This interventional prospective multicenter international study will include 54 patients with very high-risk localized (cN0 cM0) or regional (i.e. cN1 cM0) prostate cancer according the NCCN criteria.

Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. In the case of regional lymph nodes, a simultaneous integrated boost (SIB) of involved lymph nodes will be performed with 5 x 6.5 Gy. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL with 5 x 9 Gy can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.

This study is classified as risk category A according to ClinO, Art. 61, as stereotactic radiotherapy (SBRT) for localized or regional prostate cancer has been extensively evaluated in prospective interventional trials and is considered an established therapeutic modality.

Weekly CT- or MR-guided online adaptive SBRT to the prostate and elective pelvic lymph nodes with 5 × 5 Gy is, however, not yet routinely implemented for this specific patient population.

A diagnostic high field MRI during radiotherapy, e.g. week 3 is optional.

Follow-up is also according to standard of care (except for patient reported outcome measure using QLQ-C30 and QLQ-PR25 and a diagnostic MRI at 9 months after SBRT (optional), and 12 months in the case of an image non-complete response at 9 months (optional).

Conditions

Interventions

DEVICE

weekly CT or MR online adaptive definitive SBRT

Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. In the case of regional lymph nodes, a simultaneous integrated boost (SIB) of involved lymph nodes will be performed with 5 x 6.5 Gy. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL with 5 x 9 Gy can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Matthias Guckenberger · Universitätsspital Zürich

  • Tiuri Kroese · University of Zurich

  • Matthias Guckenberger · University of Zurich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-07-31
Completion
2033-07-31

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591051 on ClinicalTrials.gov