Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderate hypo-fractionation, Ultra-hypo-fractionation.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Radiotherapy Side Effect, Metastatic Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
Overview
de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.
Detailed description
Patients with de Novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. The internationally accepted fractionation schedule is 3 Gy (Gray) x 19-20 over a course of 4 weeks.
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.
Interventions
- Radiation Moderate hypo-fractionation
Patients will receive four weeks of radiotherapy - Radiation Ultra-hypo-fractionation
Patients will receive two and a half weeks of radiotherapy
Primary outcome measures
- Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks [Time frame: 8 weeks]
- Toxicity as scored by PROM at 8 weeks [Time frame: 8 weeks]
Secondary outcome measures (1)
- Failure free survival [Time frame: 12 months, 36 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Cancercenter University hospital of Umeå — Umeå
Identifiers
NCT: NCT04612907 · Hypo-M1 1.0