Curative Image Guided Radiotherapy for Prostate Cancer

Study Overview
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Brief Summary
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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).

Official Title
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A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Radiation: radiotherapy daily verification reduced safety margins
* Radiation: radiotherapy weekly verification standard safety margins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiotherapy daily reduced<br>radiotherapy, with daily CT position verification and reduced safety margins | Radiation: radiotherapy daily verification reduced safety margins<br>* curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)<br>|
| Active Comparator: radiotherapy weekly standard<br>radiotherapy, with weekly orthogonal position verification and standard safety margins | Radiation: radiotherapy weekly verification standard safety margins<br>* curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rectal side effects | FWUO94 | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from biochemical failure |  | 3 years | 
| Overall survival |  | up to 10 years | 
| Cancer specific survival |  | up to 10 years | 
| Late genitourinary and rectal side effects |  | up to 10 years | 
| Acute genitourinary side effects |  | 10 weeks | 
| quality of life | HRQoL | up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, image-guided, adverse effects, position verification, safety margins