Clinical trial NCT05350475: Protons Vs. Photons for High-risk Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Radiotherapy Side Effect
Keywords: Proton Therapy
High Risk
Intensity Modulated Radiotherapy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Odense University Hospital
name: Aarhus University Hospital
name: Aalborg University Hospital
name: Sygehus Lillebaelt
name: Herlev and Gentofte Hospital
name: Naestved Hospital
First posted: 2022-04-28
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk disease
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)
timeFrame: 2 years
Secondary outcomes:
measure: 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)
timeFrame: 5 years
measure: Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)
timeFrame: 10 years
measure: Late GI toxicity at year 5 compared to baseline (EPIC-26)
timeFrame: 5 years
measure: Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
timeFrame: 12 weeks
measure: Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)
timeFrame: 12 weeks
measure: Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26)
timeFrame: 12 weeks
measure: Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0)
timeFrame: 12 weeks
measure: General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30)
timeFrame: 10 years
measure: Biochemical progression free survival (BCR), (Phoenix criteria)
timeFrame: 10 years
measure: Non-biochemical progression free survival (by imaging)
timeFrame: 10 years
measure: Overall survival (OS)
timeFrame: 10 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
state: Central Region
city: Copenhagen
country: Denmark
facility: Dept. of Oncology, Rigshospitalet, Denmark
state: Region Hovedstaden
city: Herlev
country: Denmark
facility: Department of Oncology, Copenhagen University Hospital Herlev
state: Region Hovedstaden
city: Aalborg
country: Denmark
facility: Dept. of Oncology, Aalborg University Hospital
state: Region north
city: Odense
country: Denmark
facility: Department of Oncology, Odense University Hospital
state: Region South
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital, Denmark
state: Region South
city: Næstved
country: Denmark
facility: Dept. of Oncology, Zealand University Hospital, Denmark
state: Region Zealand
Study officials:
affiliation: Danish Centre for Particle Therapy, Aarhus University Hospital
name: Stine Elleberg Petersen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: