Metastatic Cancer, Prostate Cancer, Radiotherapy Side Effect
Conditions
Keywords
Metastatic prostate cancer radiotherapy primary tumor
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.
Interventions
RADIATIONModerate hypo-fractionation
Patients will receive four weeks of radiotherapy
RADIATIONUltra-hypo-fractionation
Patients will receive two and a half weeks of radiotherapy
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized to one of two treatment fractionations of radiotherapy
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed Informed Consent 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
1. High burden metastatic prostate cancer including all with visceral mets. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity as scored by PROM (Patient Reported Outcome Measures) at 8 weeks | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Failure free survival | 12 months, 36 months | To evaluate the proportion of patients that are failure free at 12 and 36 months, failure free survival (FFS) |
Countries
Sweden
Contacts
Primary ContactCamilla Thellenberg Karlsson, MD, PhD
Backup ContactKarin Söderkvist, MD, PhD
Outcome results
None listed