Prostatic Neoplasms
Conditions
Keywords
radiotherapy, image-guided, adverse effects, position verification, safety margins
Brief 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).
Interventions
RADIATIONradiotherapy daily verification reduced safety margins
curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)
RADIATIONradiotherapy 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
Norwegian University of Science and Technology
Alesund Hospital
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute rectal side effects | 10 weeks | FWUO94 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 10 years | — |
| Cancer specific survival | up to 10 years | — |
| Freedom from biochemical failure | 3 years | — |
| Acute genitourinary side effects | 10 weeks | — |
| quality of life | up to 10 years | HRQoL |
| Late genitourinary and rectal side effects | up to 10 years | — |
Countries
Norway
Outcome results
None listed