NCT01550237Active, not recruiting
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 · Last updated 5 Jun 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 7 Mar 2012
- Start date
- 1 Oct 2012
- Primary completion date
- 30 Sept 2015
- Lead sponsor
- St. Olavs Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT01550237
What you commit to
- Study type: Interventional
- Participants enrolled: 260
- From 1 Oct 2012 to the primary completion date, 30 Sept 2015
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Other
- Metallic hip joint replacement
- ALAT, GT, ALP, creatinin \> 1.5 x upper normal limit
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ålesund sykehus Coordinator of this site? Confirm its status | Ålesund | Norway | Unknown status |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.