Protons vs. Photons for High-risk Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Mar 1, 2037
  • participants needed
    400
  • sponsor
    University of Aarhus
Updated on 15 May 2022

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.

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.

Details
Condition Prostate Cancer, Radiotherapy Side Effect
Treatment proton therapy, Photon therapy
Clinical Study IdentifierNCT05350475
SponsorUniversity of Aarhus
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically verified localized/locally advanced prostate cancer T1-3bN0M0 (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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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