A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Umeå University
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Moderate hypo-fractionation
Radiotherapy to the prostate delivered in 3Gy fractions x 19
Intervention: Moderate hypo-fractionation (Radiation)
Ultra hypo-fractionation
Radiotherapy to the prostate delivered in 6.1Gy fractions x 6
Intervention: Ultra-hypo-fractionation (Radiation)
Outcomes
Primary Outcomes
Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks
Time Frame: 8 weeks
Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS (Prostate Cancer Symptom Scale) bother score for urinary tract will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
Toxicity as scored by PROM at 8 weeks
Time Frame: 8 weeks
Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS bother score for bowel will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
Secondary Outcomes
- Failure free survival(12 months, 36 months)