Prostatic NeoplasmsRICNCT01550237
Curative Image Guided Radiotherapy for Prostate Cancer
A study testing radiotherapy daily verification reduced safety margins and radiotherapy weekly verification standard safety margins in people with Prostatic Neoplasms, run by St. Olavs Hospital at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- radiotherapy daily verification reduced safety margins and radiotherapy weekly verification standard safety margins
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2012to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
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
- Prostatic Neoplasms
- Being tested
- radiotherapy daily verification reduced safety margins, radiotherapy weekly verification standard safety margins
- Keywords
- radiotherapy, image-guided, adverse effects, position verification, safety margins
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapy daily verification reduced safety marginsRadiation
curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)
radiotherapy weekly verification standard safety marginsRadiation
curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm)
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy daily reduced | Experimental | radiotherapy, with daily CT position verification and reduced safety margins Receives: Radiation: radiotherapy daily verification reduced safety margins |
| radiotherapy weekly standard | Active comparator | radiotherapy, with weekly orthogonal position verification and standard safety margins Receives: Radiation: radiotherapy weekly verification standard safety margins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute rectal side effects
FWUO94
Measured: 10 weeks
Secondary outcomes (6)
Freedom from biochemical failure
Measured: 3 years
Overall survival
Measured: up to 10 years
Cancer specific survival
Measured: up to 10 years
Late genitourinary and rectal side effects
Measured: up to 10 years
Acute genitourinary side effects
Measured: 10 weeks
quality of life
HRQoL
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2015
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Alesund Hospital
- Responsible party
- Sponsor
- Investigators
- Jo Å Lund, MD PhD, Principal investigator, St Olavs Hospital, University Hospital, Trondheim, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550237
- Sponsor's protocol ID
- 2011/710
- Acronym
- RIC
- Status last verified
- Jun 2025
- First submitted
- 7 Mar 2012
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tondel 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.
PubMed 29398152
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Two Centre Trial on Daily Cone-beam vs Standard Weekly Orthogonal Image Guided Radiotherapy (IGRT) for Prostate Cancer
- ClinicalTrials.gov ID
- NCT01550237
- Acronym / sponsor ID
- RIC / 2011/710
- Conditions
- Prostatic Neoplasms
- Keywords
- radiotherapy, image-guided, adverse effects, position verification, safety margins
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Alesund Hospital
- Study start
- Oct 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiotherapy daily reduced | Experimental | Radiation: radiotherapy daily verification reduced safety marginsradiotherapy, with daily CT position verification and reduced safety margins |
| radiotherapy weekly standard | Active comparator | Radiation: radiotherapy weekly verification standard safety marginsradiotherapy, with weekly orthogonal position verification and standard safety margins |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapy daily verification reduced safety marginscurative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm) | Radiation | radiotherapy daily reduced |
| radiotherapy weekly verification standard safety marginscurative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) | Radiation | radiotherapy weekly standard |
Primary outcome
Acute rectal side effects
Time frame: 10 weeks
FWUO94
6 secondary outcomes
Freedom from biochemical failure
Time frame: 3 years
Overall survival
Time frame: up to 10 years
Cancer specific survival
Time frame: up to 10 years
Late genitourinary and rectal side effects
Time frame: up to 10 years
Acute genitourinary side effects
Time frame: 10 weeks
quality of life
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Results publication: PubMed 29398152Tondel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Å Lund, MD PhD principal investigator
St Olavs Hospital, University Hospital, Trondheim, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiotherapy daily verification reduced safety margins and radiotherapy weekly verification standard safety margins in people with Prostatic Neoplasms, run by St. Olavs Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute rectal side effects (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.