Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
400 participants
INTERVENTIONAL
2022-03-01
2037-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Proton Radiation Therapy for the Treatment of Patients with High Risk Prostate Cancer
NCT04725903
Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer
NCT01368055
Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
NCT01950351
Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
NCT05313815
Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer
NCT07325721
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Proton therapy
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.
Proton therapy
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 Therapy
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.
Photon therapy
Patients in the photon arm will receive standard treatment with photon therapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Proton therapy
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 therapy
Patients in the photon arm will receive standard treatment with photon therapy.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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).
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rigshospitalet, Denmark
OTHER
Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Sygehus Lillebaelt
OTHER
Herlev and Gentofte Hospital
OTHER
Naestved Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stine Elleberg Petersen, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Danish Centre for Particle Therapy, Aarhus University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dept. of Oncology, Rigshospitalet, Denmark
Copenhagen, Capital Region, Denmark
Department of Oncology, Copenhagen University Hospital Herlev
Herlev, Capital Region, Denmark
Department of Oncology, Aarhus University Hospital
Aarhus, Central Region, Denmark
Dept. of Oncology, Aalborg University Hospital
Aalborg, Region North, Denmark
Dept. of Oncology, Zealand University Hospital, Denmark
Næstved, Region Sjælland, Denmark
Department of Oncology, Odense University Hospital
Odense, Region South, Denmark
Department of Oncology, Vejle Hospital, Denmark
Vejle, Region South, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1-10-72-290-21
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.