Spots Global Cancer Trial Database for Protons vs. Photons for High-risk Prostate Cancer
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Trial Identification
Brief Title: 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 ID: NCT05350475
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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
Contact Details
Name: Lise Bentzen, MD.Ph.d
Affiliation: Department of Oncology, Aarhus University Hospital
Role: PRINCIPAL_INVESTIGATOR
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