A Phase 2 interventional study of Hypofractionated IMRT with focal simultaneous integrated boost and elective pelvic irradiation and Androgen Deprivation Therapy (ADT) in Prostate Cancer, Prostate Cancer Locally Advanced and Prostatic Neoplams, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to male participants. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Haukeland University Hospital · Phase 2, Interventional, and Treatment
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 191 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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The criteria were revised on the registry on Oct 30, 2026. See what changed
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 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.
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.
Time frame: Up to 10 years after radiotherapy
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.
Time frame: From 3 months up to 10 years after radiotherapy
Acute toxicity
Acute genitourinary and gastrointestinal toxicity graded by the RTOG/EORTC criteria.
Time frame: From start of radiotherapy up to 3 months after completion
Plan to share: 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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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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