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

de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.

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.

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)