Protons Vs. Photons for High-risk Prostate Cancer
- Conditions
- Prostate CancerRadiotherapy Side Effect
- Interventions
- Radiation: Proton therapyRadiation: Photon therapy
- Registration Number
- NCT05350475
- Lead Sponsor
- University of Aarhus
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 400
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Proton therapy 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. Photon Therapy 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.
- Primary Outcome Measures
Name Time Method Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26) 2 years Patient Reported Outcome The investigators 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.
- Secondary Outcome Measures
Name Time Method Late GI toxicity at year 5 compared to baseline (EPIC-26) 5 years 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
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) 5 years Physician Assessed Toxicity Number of Participants With Treatment-Related Adverse events as assessed by CTCAE v5.0
Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26) 10 years Patient Reported Outcome using on-line questionnaire to assess this outcome measure
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26) 12 weeks EPIC-26
Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26) 12 weeks EPIC-26
Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0) 12 weeks Physician Assessed Toxicity
Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0) 12 weeks Physician Assessed Toxicity
Biochemical progression free survival (BCR), (Phoenix criteria) 10 years blood test
Non-biochemical progression free survival (by imaging) 10 years Radiology assesments
General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30) 10 years Patient Reported Outcome General health related quality of life (QoL) at year 2, 5 and 10 (EORTC QLQ-C30)
Overall survival (OS) 10 years Follow up
Trial Locations
- Locations (7)
Department of Oncology, Aarhus University Hospital
🇩🇰Aarhus, Central Region, Denmark
Dept. of Oncology, Rigshospitalet, Denmark
🇩🇰Copenhagen, Region Hovedstaden, Denmark
Department of Oncology, Copenhagen University Hospital Herlev
🇩🇰Herlev, Region Hovedstaden, Denmark
Dept. of Oncology, Aalborg University Hospital
🇩🇰Aalborg, Region north, Denmark
Department of Oncology, Odense University Hospital
🇩🇰Odense, Region South, Denmark
Department of Oncology, Vejle Hospital, Denmark
🇩🇰Vejle, Region South, Denmark
Dept. of Oncology, Zealand University Hospital, Denmark
🇩🇰Næstved, Region Zealand, Denmark