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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04612907
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