Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
260 participants
INTERVENTIONAL
2012-10-31
2025-09-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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radiotherapy daily reduced
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)
radiotherapy weekly standard
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)
Interventions
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radiotherapy daily verification reduced safety margins
curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
MALE
No
Sponsors
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Norwegian University of Science and Technology
OTHER
Alesund Hospital
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Jo Å Lund, MD PhD
Role: PRINCIPAL_INVESTIGATOR
St Olavs Hospital, University Hospital, Trondheim, Norway
Locations
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Ålesund Sykehus
Ålesund, , Norway
St Olavs Hospital
Trondheim, , Norway
Countries
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References
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Tondel H, Lund JA, Lydersen S, Wanderas AD, Aksnessaether B, Jensen CA, Kaasa S, Solberg A. Radiotherapy for prostate cancer - Does daily image guidance with tighter margins improve patient reported outcomes compared to weekly orthogonal verified irradiation? Results from a randomized controlled trial. Radiother Oncol. 2018 Feb;126(2):229-235. doi: 10.1016/j.radonc.2017.10.029. Epub 2018 Feb 3.
Other Identifiers
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2011/710
Identifier Type: -
Identifier Source: org_study_id
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