Prostate CancerNCT05350475
Protons vs. Photons for High-risk Prostate Cancer
A study testing Proton therapy and Photon therapy in people with Prostate Cancer and Radiotherapy Side Effect, run by University of Aarhus at 7 sites in Denmark.
Trial summary
The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Radiotherapy Side Effect
- What is being tested?
- Proton therapy and Photon therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 7 sitesDenmark
- Study dates
- 1 Mar 2022to 1 Dec 2038
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified localized/locally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck.
- Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%)
- Indication for elective lymph node irradiation
- PSA < 100 ng/mL
- Age ≥18 years
- Performance status 0-1
Show all 10Show fewer
- Life expectancy ≥ 10 years
- Able to understand and comply with the treatment protocol
- No evidence of inflammatory bowel disease Ability to adhere to procedures for study and follow-up
- Signed informed consent to participate in the study
Who cannot join
- No previous treatment for prostate cancer
- Hip-prostheses
- Other metal devices in the pelvic region (except fiducials)
- Previous major abdominal/rectal surgery
- Any other malignancy the last five years except for basal or squamous cell skin cancer
- Unable to understand patient information or comply with treatment and safety instructions
- Unable to read and understand patient information due to cognitive disabilities or language (Danish).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Dept. of Oncology, Aalborg University Hospital
Aalborg, Region North
Department of Oncology, Aarhus University Hospital
Aarhus, Central Region, 8200
Dept. of Oncology, Rigshospitalet, Denmark
Copenhagen, Capital Region
Department of Oncology, Copenhagen University Hospital Herlev
Herlev, Capital Region, DK-2730 Herlev
Dept. of Oncology, Zealand University Hospital, Denmark
Næstved, Region Sjælland
Department of Oncology, Odense University Hospital
Odense, Region South, 5000
Department of Oncology, Vejle Hospital, Denmark
Vejle, Region South
About this study
Official title: Lymph Node Radiation Therapy With Integrated Boost to Prostate for High-risk Prostate Cancer A Randomized Phase 3 Trial Comparing Photons vs. Protons
The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.
Read the detailed description
Proton therapy (PT) is a radiation technique with possibility to spare normal pelvic organs: bladder, rectum and bowel for PC patients.
Most PC patients treated with PT receive PT to the prostate gland alone. With PT, we aim to examine PC patients in high risk with both lymph node and prostate treatment will experience less late side effects with PT compared to photon treatment.
The investigators propose a national open-labelled phase III randomized controlled trial (RCT) of proton therapy versus photon therapy of the prostate including the regional elective LN for localized/locally advanced prostate cancer patients combined with androgen deprivation therapy (ADT) aimed at 3 years. The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinical significant, measured by mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) bowel scores at 24 months and improve HRQOL. Secondary endpoints include morbidity, quality of life and survival data up to 10 years after treatment.
Update August 2026:
The primary endpoint has been updated. To consider a more meaningful clinical endpoint the investigators have decided to update the endpoint and look at a 10 points difference in EPIC-26 bowel score at 24 months follow-up instead of a 5 points difference. A new power-calculation was made based on the same assumptions and the total number of patients was changed from 400 to 102.
- Conditions
- Prostate Cancer, Radiotherapy Side Effect
- Being tested
- Proton therapy, Photon therapy
- Keywords
- Proton Therapy, High Risk, Intensity Modulated Radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton therapyRadiation
Patients in the experimental arm will receive proton therapy within the same dose and fraction schedule as patients receiving photon therapy, which is standard treatment.
Photon therapyRadiation
Patients in the photon arm will receive standard treatment with photon therapy.
| Study group | Role | What they receive |
|---|---|---|
| Proton therapy | Experimental | Radiation: Proton Therapy 78 Gray (Gy) in 39 fractions with 56 Gy to the Pelvic Lymph Nodes (LN), 5 days a week.
Androgen Deprivation Therapy (ADT) for three years, starting 3 months before Proton Therapy. Receives: Radiation: Proton therapy |
| Photon Therapy | Active comparator | Radiation: Photon Therapy 78 Gy in 39 fractions with 56 Gy to the pelvic LN, 5 days a week. ADT for three years, starting 3 months before Photon Therapy. Receives: Radiation: Photon therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Patient Reported Outcome The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 10 points, which is considered clinically significant.
Measured: 2 years
Secondary outcomes (11)
Late Genito-urinary (GU) and sexual toxicity ≥ 2 grade at year 2 and 5 compared to baseline (Common Terminology Criteria for Adverse Events (CTCAE) toxicity score (CTC_AE 5.0)
Physician Assessed Toxicity Number of Participants With Treatment-Related Adverse events as assessed by CTCAE v5.0
Measured: 5 years
Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)
Patient Reported Outcome using on-line questionnaire to assess this outcome measure
Measured: 10 years
Late GI toxicity at year 5 compared to baseline (EPIC-26)
Patient Reported Outcome using on-line questionnaire to assess this outcome measure.aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinically significant, measured by mean points, which is considered clinically significant
Measured: 5 years
Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
EPIC-26
Measured: 12 weeks
Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)
Physician Assessed Toxicity
Measured: 12 weeks
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
EPIC-26
Measured: 12 weeks
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0)
Physician Assessed Toxicity
Measured: 12 weeks
General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30)
Patient Reported Outcome General health related quality of life (QoL) at year 2, 5 and 10 (EORTC QLQ-C30)
Measured: 10 years
Biochemical progression free survival (BCR), (Phoenix criteria)
blood test
Measured: 10 years
Non-biochemical progression free survival (by imaging)
Radiology assesments
Measured: 10 years
Overall survival (OS)
Follow up
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Mar 2022
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Model description
- A randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk disease
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Sygehus Lillebaelt, Herlev and Gentofte Hospital, Naestved Hospital
- Responsible party
- Sponsor
- Investigators
- Stine Elleberg Petersen, MD, Ph.D, Principal investigator, Danish Centre for Particle Therapy, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350475
- Sponsor's protocol ID
- 1-10-72-290-21
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Radiation Therapy With Integrated Boost to Prostate for High-risk Prostate Cancer A Randomized Phase 3 Trial Comparing Photons vs. Protons
- ClinicalTrials.gov ID
- NCT05350475
- Acronym / sponsor ID
- 1-10-72-290-21
- Conditions
- Prostate Cancer, Radiotherapy Side Effect
- Keywords
- Proton Therapy, High Risk, Intensity Modulated Radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aarhus University Hospital, Aalborg University Hospital, Sygehus Lillebaelt, Herlev and Gentofte Hospital, Naestved Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2038 (estimated)
- First posted
- 28 Apr 2022 (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.
The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.
Detailed description
Proton therapy (PT) is a radiation technique with possibility to spare normal pelvic organs: bladder, rectum and bowel for PC patients.
Most PC patients treated with PT receive PT to the prostate gland alone. With PT, we aim to examine PC patients in high risk with both lymph node and prostate treatment will experience less late side effects with PT compared to photon treatment.
The investigators propose a national open-labelled phase III randomized controlled trial (RCT) of proton therapy versus photon therapy of the prostate including the regional elective LN for localized/locally advanced prostate cancer patients combined with androgen deprivation therapy (ADT) aimed at 3 years. The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinical significant, measured by mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) bowel scores at 24 months and improve HRQOL. Secondary endpoints include morbidity, quality of life and survival data up to 10 years after treatment.
Update August 2026:
The primary endpoint has been updated. To consider a more meaningful clinical endpoint the investigators have decided to update the endpoint and look at a 10 points difference in EPIC-26 bowel score at 24 months follow-up instead of a 5 points difference. A new power-calculation was made based on the same assumptions and the total number of patients was changed from 400 to 102.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk disease
| Arm | Type | Receives |
|---|---|---|
| Proton therapy | Experimental | Radiation: Proton therapyRadiation: Proton Therapy 78 Gray (Gy) in 39 fractions with 56 Gy to the Pelvic Lymph Nodes (LN), 5 days a week. Androgen Deprivation Therapy (ADT) for three years, starting 3 months before Proton Therapy. |
| Photon Therapy | Active comparator | Radiation: Photon therapyRadiation: Photon Therapy 78 Gy in 39 fractions with 56 Gy to the pelvic LN, 5 days a week. ADT for three years, starting 3 months before Photon Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically verified localized/locally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck.
- Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%)
- Indication for elective lymph node irradiation
- PSA < 100 ng/mL
- Age ≥18 years
Key exclusion criteria (7 listed)
- No previous treatment for prostate cancer
- Hip-prostheses
- Other metal devices in the pelvic region (except fiducials)
- Previous major abdominal/rectal surgery
- Any other malignancy the last five years except for basal or squamous cell skin cancer
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 |
|---|---|---|
| Proton therapyPatients in the experimental arm will receive proton therapy within the same dose and fraction schedule as patients receiving photon therapy, which is standard treatment. | Radiation | Proton therapy |
| Photon therapyPatients in the photon arm will receive standard treatment with photon therapy. | Radiation | Photon Therapy |
Primary outcome
Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Time frame: 2 years
Patient Reported Outcome The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 10 points, which is considered clinically significant.
11 secondary outcomes
Late Genito-urinary (GU) and sexual toxicity ≥ 2 grade at year 2 and 5 compared to baseline (Common Terminology Criteria for Adverse Events (CTCAE) toxicity score (CTC_AE 5.0)
Time frame: 5 years
Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)
Time frame: 10 years
Late GI toxicity at year 5 compared to baseline (EPIC-26)
Time frame: 5 years
Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
Time frame: 12 weeks
Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)
Time frame: 12 weeks
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
Time frame: 12 weeks
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0)
Time frame: 12 weeks
General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30)
Time frame: 10 years
Biochemical progression free survival (BCR), (Phoenix criteria)
Time frame: 10 years
Non-biochemical progression free survival (by imaging)
Time frame: 10 years
Overall survival (OS)
Time frame: 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 13 Aug 2026.
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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.
Stine Elleberg Petersen, MD, Ph.D principal investigator
Danish Centre for Particle Therapy, Aarhus University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton therapy and Photon therapy in people with Prostate Cancer and Radiotherapy Side Effect, run by University of Aarhus at 7 sites in Denmark.
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 10 inclusion and 7 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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?
Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.