Prostate Cancer, Radiotherapy Side Effect
Conditions
Keywords
Proton Therapy, High Risk, Intensity Modulated Radiotherapy
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.
Interventions
RADIATIONProton 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.
RADIATIONPhoton therapy
Patients in the photon arm will receive standard treatment with photon therapy.
Sponsors
Rigshospitalet, Denmark
Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
Sygehus Lillebaelt
Herlev and Gentofte Hospital
Naestved Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized phase 3 study, randomizing 1:1 between photon vs. proton therapy for prostate cancer patients with high risk disease
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 (EPIC-26) | 12 weeks | EPIC-26 |
| 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 |
| 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) |
| Biochemical progression free survival (BCR), (Phoenix criteria) | 10 years | blood test |
| Non-biochemical progression free survival (by imaging) | 10 years | Radiology assesments |
| Overall survival (OS) | 10 years | Follow up |
| 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 |
Countries
Denmark
Contacts
Primary ContactStine Elleberg Petersen, MD, Ph.D
Outcome results
None listed