Lymph Node Radiation Therapy With Integrated Boost to Prostate for High-risk Prostate Cancer A Randomized Phase 3 Trial Comparing Photons vs. Protons
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 102
- Locations
- 7
- Primary Endpoint
- Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Proton therapy (Radiation)
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.
Intervention: Photon therapy (Radiation)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Late GI toxicity at year 5 compared to baseline (EPIC-26)(5 years)
- 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)
- Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)(10 years)
- Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26)(12 weeks)
- Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)(12 weeks)
- Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)(12 weeks)
- Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0)(12 weeks)
- Biochemical progression free survival (BCR), (Phoenix criteria)(10 years)
- Non-biochemical progression free survival (by imaging)(10 years)
- General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30)(10 years)
- Overall survival (OS)(10 years)