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Curative Image Guided Radiotherapy for Prostate Cancer

NCT01550237 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-06-05

No results posted yet for this study

Summary

The clinical importance of cone beam computer tomography based image guided radiotherapy (CT- IGRT) has not been established. The primary aim of the present trial is to investigate whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as secondary outcome.

An open randomised phase III trial. The included men will be randomised to receive curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm).

Conditions

  • Prostatic Neoplasms

Interventions

RADIATION

radiotherapy daily verification reduced safety margins

curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)

RADIATION

radiotherapy weekly verification standard safety margins

curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm)

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Alesund Hospital

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Jo Å Lund, MD PhD · St Olavs Hospital, University Hospital, Trondheim, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-09-30
Completion
2025-09-30

Countries

  • Norway

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 NCT01550237 on ClinicalTrials.gov