Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Treatments radiotherapy daily verification reduced safety margins, radiotherapy weekly verification standard safety margins
Sponsor St. Olavs Hospital
Collaborator Norwegian University of Science and Technology
Start date October 2012
End date September 2015
Trial size 260 participants
Trial identifier NCT01550237, 2011/710

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
radiotherapy, with daily CT position verification and reduced safety margins
radiotherapy daily verification reduced safety margins
curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)
(Active Comparator)
radiotherapy, with weekly orthogonal position verification and standard safety margins
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)

Primary Outcomes

Measure
Acute rectal side effects
time frame: 10 weeks

Secondary Outcomes

Measure
Freedom from biochemical failure
time frame: 3 years
Overall survival
time frame: up to 10 years
Cancer specific survival
time frame: up to 10 years
Late genitourinary and rectal side effects
time frame: up to 10 years
Acute genitourinary side effects
time frame: 10 weeks
quality of life
time frame: up to 10 years

Eligibility Criteria

Male participants from 18 years up to 80 years old.

Inclusion Criteria: - Biopsy confirmed adenocarcinoma of prostate - No evidence of nodal or distant metastases (N0M0) - Intermediate or high risk based on T stage, PSA level and Gleason score - Informed consent Exclusion Criteria: - Previous treatment for cancer last 5 years, except basal cell carcinoma of skin - Any previous radiotherapy, except KV or electron treatment of skin tumors outside the pelvis - Metallic hip joint replacement - Pre-existing intestinal or genitourinary disease with increased risk of side effects - Any pre-existing condition making the patient unsuitable for radiotherapy - Any pre-existing condition making the patient unsuitable for hormonal therapy - Any pre-existing condition making the patient unsuitable for MRI. - ALAT, GT, ALP, creatinin > 1.5 x upper normal limit

Additional Information

Official title A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
Principal investigator Jo Å Lund, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by St. Olavs Hospital.