RecruitingNot ApplicableNCT04612907

Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer


Sponsor

Umeå University

Enrollment

420 participants

Start Date

Oct 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria4

  • Signed Informed Consent
  • Histological confirmed prostate cancer
  • Indication for early palliative radiation therapy of low burden metastatic prostate cancer. Low burden as defined by modified CHAARTED trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes
  • baseline E-PROM

Exclusion Criteria5

  • High burden metastatic prostate cancer including all with visceral mets.
  • Unable to comply with study procedures.
  • Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy
  • Radiation treatment start later than nine months after the prostate cancer diagnosis.
  • Severe micturition problems, IPSS \> 20 ( International Prostate Symptom Score)

Interventions

RADIATIONModerate hypo-fractionation

Patients will receive four weeks of radiotherapy

RADIATIONUltra-hypo-fractionation

Patients will receive two and a half weeks of radiotherapy


Locations(1)

Cancercenter University hospital of Umeå

Umeå, Sweden

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NCT04612907


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