Protons vs. Photons for High-risk Prostate Cancer

N/AActive Not RecruitingNCT05350475

University of Aarhus102 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Prostate Cancer Radiotherapy Side Effect

Interventions

Proton therapyRADIATION

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.

Photon therapyRADIATION

Patients in the photon arm will receive standard treatment with photon therapy.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (7)

Dept. of Oncology, Rigshospitalet, Denmark

Copenhagen, Capital Region, Denmark

Department of Oncology, Copenhagen University Hospital Herlev

Herlev, Capital Region, Denmark

Department of Oncology, Aarhus University Hospital

Aarhus, Central Region, Denmark

Dept. of Oncology, Aalborg University Hospital

Outcomes

Primary Outcomes

Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26)

Patient Reported Outcome The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 10 points, which is considered clinically significant.

Time frame: 2 years

Secondary Outcomes

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)

Physician Assessed Toxicity Number of Participants With Treatment-Related Adverse events as assessed by CTCAE v5.0

Time frame: 5 years

Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26)

Patient Reported Outcome using on-line questionnaire to assess this outcome measure

Time frame: 10 years

Late GI toxicity at year 5 compared to baseline (EPIC-26)

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

Time frame: 5 years

Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26)

EPIC-26

Time frame: 12 weeks

Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0)

Physician Assessed Toxicity

Time frame: 12 weeks

Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26)

Data from ClinicalTrials.gov

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