Protons Vs. Photons for High-risk Prostate Cancer

University of Aarhus

Status: Enrolling

Conditions: Radiotherapy Side Effect; Prostate Cancer

Treatments: Radiation: Proton therapy; Radiation: Photon therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05350475

1-10-72-290-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Proton therapy

Experimental group

Description:

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.

Treatment:

Radiation: Proton therapy

Photon Therapy

Active Comparator group

Description:

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.

Treatment:

Radiation: Photon therapy