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Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence

NCT03438552 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-12-20

No results posted yet for this study

Summary

Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy.

The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment.

The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.

Conditions

  • Local Recurrence of Malignant Tumor of Prostate

Interventions

RADIATION

Stereotactic Body Radiotherapy

This radiotherapy may be administered with the CyberKnife® or a linear accelerator allowing stereotactic radiotherapy.

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • David Pasquier · Centre Oscar Lambret, LILLE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2027-10-15
Completion
2030-11-30

Countries

  • France

Study Locations

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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 NCT03438552 on ClinicalTrials.gov