Clinical trial · Interventional
Curative Image Guided Radiotherapy for Prostate Cancer
A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy daily verification reduced safety margins | Radiation | — | UNRESOLVED |
| radiotherapy weekly verification standard safety margins | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- radiotherapy daily reduced
- description
- radiotherapy, with daily CT position verification and reduced safety margins
- interventionNames
- Radiation: radiotherapy daily verification reduced safety margins
- type
- ACTIVE_COMPARATOR
- label
- radiotherapy weekly standard
- description
- radiotherapy, with weekly orthogonal position verification and standard safety margins
- interventionNames
- Radiation: radiotherapy weekly verification standard safety margins
Primary outcomes (1)
- measure
- Acute rectal side effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTTondel 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. PMID 29398152