A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
N/A
18 Years
80 Years
18 Years
80 Years
Open (Enrolling)
Male
Prostatic Neoplasms
Male
Prostatic Neoplasms
Trial Information
A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acute rectal side effects
Outcome Description:
FWUO94
Outcome Time Frame:
10 weeks
Safety Issue:
No
Principal Investigator
Jo Å Lund, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St Olavs Hospital, University Hospital, Trondheim, Norway
Authority:
Norway:National Committee for Medical and Health Research Ethics
Study ID:
2011/710
NCT ID:
NCT01550237
Start Date:
October 2012
Completion Date:
October 2014
Related Keywords:
- Prostatic Neoplasms
- radiotherapy, image-guided
- adverse effects
- position verification
- safety margins
- Neoplasms
- Prostatic Neoplasms
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