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A Phase I-II Study on Stereotactic Body Radiotherapy in 3 Fractions for Low/Int Risk Prostate Cancer

NCT02623647 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-03-09

No results posted yet for this study

Summary

The present is a phase I-II study testing the safety and the efficacy of extremely hypofractionated radiotherapy for early stage prostate cancer. The study is designed to assess GU toxicity while controlling tumor control, in terms of survival free from biochemical failure. 40 Gy in fxs will be delivered to patients with low and favourable intermediate risk prostate tumors.

Conditions

Interventions

RADIATION

stereotactic body radiotherapy SBRT

40 Gy in 3 fractions to the prostate gland delivered with stereotactic body radiotherapy

Sponsors & Collaborators

  • San Giovanni Addolorata Hospital

    collaborator OTHER

  • Azienda Sanitaria-Universitaria Integrata di Udine

    collaborator OTHER

  • Regina Elena Cancer Institute

    lead OTHER

Principal Investigators

  • Giuseppe Sanguineti, MD · Regina Elena National Cancer Institute, Rome IT

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2021-03-31
Completion
2022-01-31

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 NCT02623647 on ClinicalTrials.gov