MedTrace Logo

ABlative Radiotherapy (for) Unfavorable Prostate Tumors 2.0

NCT07407608 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2026-02-12

No results posted yet for this study

Summary

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines. The results of the study will enable us to find out if the new, shorter treatment (1 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.

Conditions

  • Prostate Cancer
  • Prostate Cancer (Adenocarcinoma)
  • Prostate Cancer Non-Metastatic

Interventions

RADIATION

SBRT

Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.

RADIATION

SDRT

Single Dose Radiation Therapy. Ultrahypofractionated radiotherapy.

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2029-07-31
Completion
2034-07-31

Countries

  • Italy

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 NCT07407608 on ClinicalTrials.gov