Prostate CancerPhase 2NCT07900555
Hypofractionated Radiotherapy With Magnetic Resonance Imaging-Guided Focal Boost and Pelvic Irradiation in High-Risk Prostate Cancer
A Phase 2 study testing Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiation and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer and Prostate Cancer Locally Advanced, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
This study evaluated long-term disease control and side effects of a moderately hypofractionated radiotherapy protocol for men with high-risk prostate cancer. The protocol combined three strategies in one course of 25 treatments: a higher dose (focal boost) to the tumor seen on magnetic resonance imaging (MRI), a… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Locally Advanced, Prostatic Neoplams
- What is being tested?
- Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiation and Androgen Deprivation Therapy (ADT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteNorway
- Study dates
- 24 Feb 2014to 1 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Morphologically confirmed prostate cancer
- TNM stage T3-T4, N0-1, M0 tumors, or lower T stage with an estimated risk of lymph node metastases above 15% according to the Memorial Sloan Kettering Cancer Center nomogram
- Life expectancy of more than 5 years
- Adequate cognitive function
- Written informed consent
Who cannot join
- Distant metastases
- Lymph node metastases cranial to the level of the fifth lumbar vertebra (L5)
- Inflammatory bowel disease, pronounced irritable bowel syndrome, or other severe comorbidity contraindicating local radiotherapy
- Previous pelvic radiotherapy
- Hemochromatosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-Escalated Image-Guided Radiotherapy (IGRT) With Magnetic Resonance Imaging (MRI)-Based Target Definition for Locally and Regionally Advanced Prostate Cancer: A Phase II Study
This study evaluated long-term disease control and side effects of a moderately hypofractionated radiotherapy protocol for men with high-risk prostate cancer. The protocol combined three strategies in one course of 25 treatments: a higher dose (focal boost) to the tumor seen on magnetic resonance imaging (MRI), a reduced dose to the uninvolved parts of the prostate, and elective irradiation of the pelvic lymph nodes, together with hormone therapy. Patients were included at Haukeland University Hospital, Bergen, Norway, from 2014 to 2017, with outcomes evaluated up to 10 years after treatment.
Read the detailed description
Background: Three developments have each been shown to improve or simplify radiotherapy for prostate cancer: moderate hypofractionation, a focal boost to the dominant intraprostatic lesion, and elective pelvic lymph node irradiation in high-risk disease. Long-term data on combining all three in one protocol are lacking. A previous institutional phase II study (2007-2009) used a hypofractionated simultaneous integrated boost with uniform dose to the prostate and an elective pelvic field.
Design: Prospective, single-arm study at Haukeland University Hospital. Patients with high-risk prostate cancer, including clinically node-positive disease, were included from February 2014 to June 2017. For analysis, patients were grouped as high risk, very high risk, and node-positive.
Treatment: Image-guided intensity-modulated radiotherapy (IMRT) in 25 fractions with a simultaneous integrated boost of 2.9 Gray (Gy) per fraction (72.5 Gy) to the MRI-defined tumor, 2.4 Gy per fraction (60 Gy) to the uninvolved prostate and seminal vesicles, and 2.0 Gy per fraction (50 Gy) to the elective pelvic lymph nodes in all patients, with a simultaneous boost of 2.4 Gy per fraction (60 Gy) to involved lymph nodes in node-positive patients. Androgen deprivation therapy was planned for 18 months.
Follow-up: Patients were followed with prostate-specific antigen (PSA) measurements and clinical examinations every 6 months for 5 years and annually thereafter. The protocol did not specify an end of follow-up; data collection was closed on 1 October 2025, and outcomes are reported up to 10 years. Endpoints are listed under Outcome Measures. Toxicity was physician-reported.
Registration: The study was approved by the Regional Committee for Medical and Health Research Ethics (2012/1863) before inclusion started. It was registered at ClinicalTrials.gov retrospectively, after completion of follow-up; this record reflects the ethics-approved protocol.
- Being tested
- Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiation, Androgen Deprivation Therapy (ADT)
- Keywords
- high-risk prostate cancer, hypofractionated radiotherapy, focal boost, simultaneous integrated boost, elective pelvic irradiation, image-guided radiotherapy, IMRT, MRI-based target definition, androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiationRadiation
Image-guided IMRT in 25 fractions: 2.9 Gy/fraction (72.5 Gy) to the MRI-defined tumour, 2.4 Gy/fraction (60 Gy) to the uninvolved prostate and seminal vesicles, and 2.0 Gy/fraction (50 Gy) to the elective pelvic lymph nodes, with a boost of 2.4 Gy/fraction (60 Gy) to involved lymph nodes in node-positive patients.
Androgen Deprivation Therapy (ADT)Drug
Androgen deprivation therapy started approximately 3 months before radiotherapy: an luteinizing hormone-releasing hormone (LHRH) analogue with at least 4 weeks of antiandrogen, or alternatively an LHRH antagonist. Planned duration 18 months if clinically tolerated. Antiandrogen monotherapy was an option in case of poor tolerance of the LHRH analogue.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated focal boost radiotherapy | Experimental | Image-guided IMRT in 25 fractions: 2.9 Gy/fraction (72.5 Gy) to the MRI-defined tumour, 2.4 Gy/fraction (60 Gy) to the uninvolved prostate and seminal vesicles, and 2.0 Gy/fraction (50 Gy) to the elective pelvic lymph nodes, with a boost of 2.4 Gy/fraction (60 Gy) to involved lymph nodes in node-positive patients; androgen deprivation therapy planned for 18 months. Receives: Radiation: Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiation; Drug: Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Biochemical Disease Control
Freedom from biochemical failure (Phoenix definition: PSA nadir + 2 ng/mL) or clinical failure (local, regional or distant recurrence), whichever occurs first.
Measured: Up to 10 years after radiotherapy
Secondary outcomes (2)
Late Toxicity
Late genitourinary and gastrointestinal toxicity graded by the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring schema.
Measured: From 3 months up to 10 years after radiotherapy
Acute toxicity
Acute genitourinary and gastrointestinal toxicity graded by the RTOG/EORTC criteria.
Measured: From start of radiotherapy up to 3 months after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start24 Feb 2014
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received the same protocol radiotherapy. For analysis, patients were grouped as high risk, very high risk and node-positive.
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Svein I Helle, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900555
- Sponsor's protocol ID
- REK 2012/1863
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be shared openly because of Norwegian data protection legislation and the terms of the ethics approval. Requests for de-identified data can be directed to the principal investigator and require approval from the ethics committee and the hospital's data protection officer.
Publications
Ekanger C, Helle SI, Heinrich D, Johannessen DC, Karlsdottir A, Nygard Y, Halvorsen OJ, Reisaeter L, Kvale R, Hysing LB, Dahl O. Ten-Year Results From a Phase II Study on Image Guided, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost in High-Risk Prostate Cancer. Adv Radiat Oncol. 2019 Dec 9;5(3):396-403. doi: 10.1016/j.adro.2019.11.007. eCollection 2020 May-Jun.
PubMed 32529133
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Escalated Image-Guided Radiotherapy (IGRT) With Magnetic Resonance Imaging (MRI)-Based Target Definition for Locally and Regionally Advanced Prostate Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT07900555
- Acronym / sponsor ID
- REK 2012/1863
- Keywords
- high-risk prostate cancer, hypofractionated radiotherapy, focal boost, simultaneous integrated boost, elective pelvic irradiation, image-guided radiotherapy, IMRT, MRI-based target definition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 24 Feb 2014 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 28 Oct 2026 (actual)
- 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.
This study evaluated long-term disease control and side effects of a moderately hypofractionated radiotherapy protocol for men with high-risk prostate cancer. The protocol combined three strategies in one course of 25 treatments: a higher dose (focal boost) to the tumor seen on magnetic resonance imaging (MRI), a reduced dose to the uninvolved parts of the prostate, and elective irradiation of the pelvic lymph nodes, together with hormone therapy. Patients were included at Haukeland University Hospital, Bergen, Norway, from 2014 to 2017, with outcomes evaluated up to 10 years after treatment.
Detailed description
Background: Three developments have each been shown to improve or simplify radiotherapy for prostate cancer: moderate hypofractionation, a focal boost to the dominant intraprostatic lesion, and elective pelvic lymph node irradiation in high-risk disease. Long-term data on combining all three in one protocol are lacking. A previous institutional phase II study (2007-2009) used a hypofractionated simultaneous integrated boost with uniform dose to the prostate and an elective pelvic field.
Design: Prospective, single-arm study at Haukeland University Hospital. Patients with high-risk prostate cancer, including clinically node-positive disease, were included from February 2014 to June 2017. For analysis, patients were grouped as high risk, very high risk, and node-positive.
Treatment: Image-guided intensity-modulated radiotherapy (IMRT) in 25 fractions with a simultaneous integrated boost of 2.9 Gray (Gy) per fraction (72.5 Gy) to the MRI-defined tumor, 2.4 Gy per fraction (60 Gy) to the uninvolved prostate and seminal vesicles, and 2.0 Gy per fraction (50 Gy) to the elective pelvic lymph nodes in all patients, with a simultaneous boost of 2.4 Gy per fraction (60 Gy) to involved lymph nodes in node-positive patients. Androgen deprivation therapy was planned for 18 months.
Follow-up: Patients were followed with prostate-specific antigen (PSA) measurements and clinical examinations every 6 months for 5 years and annually thereafter. The protocol did not specify an end of follow-up; data collection was closed on 1 October 2025, and outcomes are reported up to 10 years. Endpoints are listed under Outcome Measures. Toxicity was physician-reported.
Registration: The study was approved by the Regional Committee for Medical and Health Research Ethics (2012/1863) before inclusion started. It was registered at ClinicalTrials.gov retrospectively, after completion of follow-up; this record reflects the ethics-approved protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received the same protocol radiotherapy. For analysis, patients were grouped as high risk, very high risk and node-positive.
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated focal boost radiotherapy | Experimental | Radiation: Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiation, Drug: Androgen Deprivation Therapy (ADT)Image-guided IMRT in 25 fractions: 2.9 Gy/fraction (72.5 Gy) to the MRI-defined tumour, 2.4 Gy/fraction (60 Gy) to the uninvolved prostate and seminal vesicles, and 2.0 Gy/fraction (50 Gy) to the elective pelvic lymph nodes, with a boost of 2.4 Gy/fraction (60 Gy) to involved lymph nodes in node-positive patients; androgen deprivation therapy planned for 18 months. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Morphologically confirmed prostate cancer
- TNM stage T3-T4, N0-1, M0 tumors, or lower T stage with an estimated risk of lymph node metastases above 15% according to the Memorial Sloan Kettering Cancer Center nomogram
- Life expectancy of more than 5 years
- Adequate cognitive function
- Written informed consent
Key exclusion criteria (5 listed)
- Distant metastases
- Lymph node metastases cranial to the level of the fifth lumbar vertebra (L5)
- Inflammatory bowel disease, pronounced irritable bowel syndrome, or other severe comorbidity contraindicating local radiotherapy
- Previous pelvic radiotherapy
- Hemochromatosis
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 |
|---|---|---|
| Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiationImage-guided IMRT in 25 fractions: 2.9 Gy/fraction (72.5 Gy) to the MRI-defined tumour, 2.4 Gy/fraction (60 Gy) to the uninvolved prostate and seminal vesicles, and 2.0 Gy/fraction (50 Gy) to the elective pelvic lymph nodes, with a boost of 2.4 Gy/fraction (60 Gy) to involved lymph nodes in node-positive patients. | Radiation | Hypofractionated focal boost radiotherapy |
| Androgen Deprivation Therapy (ADT)Androgen deprivation therapy started approximately 3 months before radiotherapy: an luteinizing hormone-releasing hormone (LHRH) analogue with at least 4 weeks of antiandrogen, or alternatively an LHRH antagonist. Planned duration 18 months if clinically tolerated. Antiandrogen monotherapy was an option in case of poor tolerance of the LHRH analogue. | Drug | Hypofractionated focal boost radiotherapy |
Primary outcome
Clinical and Biochemical Disease Control
Time frame: Up to 10 years after radiotherapy
Freedom from biochemical failure (Phoenix definition: PSA nadir + 2 ng/mL) or clinical failure (local, regional or distant recurrence), whichever occurs first.
2 secondary outcomes
Late Toxicity
Time frame: From 3 months up to 10 years after radiotherapy
Acute toxicity
Time frame: From start of radiotherapy up to 3 months after completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 32529133Ekanger C, Helle SI, Heinrich D, Johannessen DC, Karlsdottir A, Nygard Y, Halvorsen OJ, Reisaeter L, Kvale R, Hysing LB, Dahl O. Ten-Year Results From a Phase II Study on Image Guided, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost in High-Risk Prostate Cancer. Adv Radiat Oncol. 2019 Dec 9;5(3):396-403. doi: 10.1016/j.adro.2019.11.007. eCollection 2020 May-Jun.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared openly because of Norwegian data protection legislation and the terms of the ethics approval. Requests for de-identified data can be directed to the principal investigator and require approval from the ethics committee and the hospital's data protection officer.
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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.
Svein I Helle, MD, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiation and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer and Prostate Cancer Locally Advanced, run by Haukeland University Hospital at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical and Biochemical Disease Control (time frame: Up to 10 years after radiotherapy). 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 NCT07900555, 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 30 Oct 2026.