Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

Conditions
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Prostate Cancer, Radiotherapy Side Effect, Metastatic Cancer

Intervention / Treatment
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* Radiation: Moderate hypo-fractionation
* Radiation: Ultra-hypo-fractionation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to one of two treatment fractionations of radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moderate hypo-fractionation<br>Radiotherapy to the prostate delivered in 3Gy fractions x 19 | Radiation: Moderate hypo-fractionation<br>* Patients will receive four weeks of radiotherapy<br>|
| Experimental: Ultra hypo-fractionation<br>Radiotherapy to the prostate delivered in 6.1Gy fractions x 6 | Radiation: Ultra-hypo-fractionation<br>* Patients will receive two and a half weeks of radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as scored by PROM (Patient Reported Outcome Measures) at 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 | 8 weeks | 
| Toxicity as scored by PROM at 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure free survival | To evaluate the proportion of patients that are failure free at 12 and 36 months, failure free survival (FFS) | 12 months, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic prostate cancer radiotherapy primary tumor