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Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

NCT04141709 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-02-08

No results posted yet for this study

Summary

The purpose of this randomized trial is to investigate the efficacy and toxicity of percutaneous high-dose radiotherapy in patients with oligometastases of hormone refractory prostate cancer. The effectiveness will be tested in comparison to an observation group, in which no further therapy is initially given. Treatment can be stereotactically hypofractionated or conventionally fractionated.

Conditions

  • Oligometastatic Disease
  • Prostatic Cancer, Castration-Resistant

Interventions

RADIATION

local ablative radiotherapy

Within the scope of the study, irradiation with two irradiation schemes is possible (the scheme applied is recorded in the CRF): * Scheme A 3\*10 Gy (once a day, 2-3 days a week) * Scheme B 25\*2 Gy (once a day, 5 days a week) The decision which irradiation scheme (3\*10 Gy or 25\*2 Gy) to use is made by the treating physician based on the anatomical position, the size of the metastases and the expected normal tissue load. Hypofractionated irradiation in three fractions is only possible if the limit values for the risk organs are adhered to. Radiotherapy should be performed with photons.

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Tobias Hölscher, Dr. · Radiation Oncology, Technische Universität Dresden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2024-02-28
Completion
2025-02-28

Countries

  • Germany

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 NCT04141709 on ClinicalTrials.gov