Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
NCT ID: NCT04612907
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
420 participants
INTERVENTIONAL
2022-10-31
2032-09-30
Brief Summary
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Detailed Description
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There is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. We will test if the schedule of 6.1Gy x 6 compares to standard of 3 Gy x 19 with regard to patient reported side-effects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Moderate hypo-fractionation
Radiotherapy to the prostate delivered in 3Gy fractions x 19
Moderate hypo-fractionation
Patients will receive four weeks of radiotherapy
Ultra hypo-fractionation
Radiotherapy to the prostate delivered in 6.1Gy fractions x 6
Ultra-hypo-fractionation
Patients will receive two and a half weeks of radiotherapy
Interventions
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Moderate hypo-fractionation
Patients will receive four weeks of radiotherapy
Ultra-hypo-fractionation
Patients will receive two and a half weeks of radiotherapy
Eligibility Criteria
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Inclusion Criteria
2. Histological confirmed prostate cancer
3. 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
4. baseline E-PROM
Exclusion Criteria
2. Unable to comply with study procedures.
3. Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy
4. Radiation treatment start later than nine months after the prostate cancer diagnosis.
5. Severe micturition problems, IPSS \> 20 ( International Prostate Symptom Score)
18 Years
MALE
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Camilla of T Karlsson
Role: PRINCIPAL_INVESTIGATOR
Cancercentrum Umeå University
Locations
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Cancercenter University hospital of Umeå
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Hypo-M1 1.0
Identifier Type: -
Identifier Source: org_study_id
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