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NCT Number: NCT05350475

Protons Vs. Photons for High-risk Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Radiation Injuries Radiotherapy Side Effect Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Oncology, Rigshospitalet, Denmark, Copenhagen, Capital Region, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

proton therapy

Radiation

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 therapy

Radiation

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. 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)

    Time frame: 5 years

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

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

    Time frame: 10 years

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

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

    Time frame: 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

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

    Time frame: 12 weeks

    EPIC-26

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

    Time frame: 12 weeks

    Physician Assessed Toxicity

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

    Time frame: 12 weeks

    EPIC-26

  7. Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0)

    Time frame: 12 weeks

    Physician Assessed Toxicity

  8. General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30)

    Time frame: 10 years

    Patient Reported Outcome General health related quality of life (QoL) at year 2, 5 and 10 (EORTC QLQ-C30)

  9. Biochemical progression free survival (BCR), (Phoenix criteria)

    Time frame: 10 years

    blood test

  10. Non-biochemical progression free survival (by imaging)

    Time frame: 10 years

    Radiology assesments

  11. Overall survival (OS)

    Time frame: 10 years

    Follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Stine Elleberg Petersen, MD, Ph.D

CONTACT

[email protected]

+4529474408

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Herlev and Gentofte Hospital
  • Naestved Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • Sygehus Lillebaelt

Registry information

Official study title

Lymph Node Radiation Therapy with Integrated Boost to Prostate for High-risk Prostate Cancer a Randomized Phase 3 Trial Comparing Photons Vs. Protons

Important dates

Study start
2022
Primary completion
2027
Study completion
2037
First posted
Apr 28, 2022
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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