Protons Vs. Photons for High-risk Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proton therapy, Photon therapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Radiotherapy Side Effect. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Radiation 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. - Radiation Photon therapy
Patients in the photon arm will receive standard treatment with photon therapy.
Primary outcome measures
- Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26) [Time frame: 2 years]
Secondary outcome measures (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) [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]
Eligibility criteria
Inclusion criteria
- 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
- 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
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 7 centers
- Dept. of Oncology, Rigshospitalet, Denmark — Copenhagen
- Department of Oncology, Copenhagen University Hospital Herlev — Herlev
- Department of Oncology, Aarhus University Hospital — Aarhus
- Dept. of Oncology, Aalborg University Hospital — Aalborg
- Dept. of Oncology, Zealand University Hospital, Denmark — Næstved
- Department of Oncology, Odense University Hospital — Odense
- Department of Oncology, Vejle Hospital, Denmark — Vejle
Identifiers
NCT: NCT05350475 · 1-10-72-290-21