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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate hypo-fractionation | Active Comparator | Radiotherapy to the prostate delivered in 3Gy fractions x 19 |
|
| Ultra hypo-fractionation | Experimental | Radiotherapy to the prostate delivered in 6.1Gy fractions x 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate hypo-fractionation | Radiation | Patients will receive four weeks of radiotherapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Prostate cancer is a male disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camilla Thellenberg Karlsson, MD, PhD | Contact | +46 90 785 3296 | camilla.thellenberg@umu.se | |
| Karin Söderkvist, MD, PhD | Contact | +4690 785 00 00 | karin.soderkvist@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Camilla of T Karlsson | Cancercentrum Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancercenter University hospital of Umeå | Recruiting | Umeå | 90596 | Sweden |
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Patients will be randomized to one of two treatment fractionations of radiotherapy
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| Ultra-hypo-fractionation | Radiation | Patients will receive two and a half weeks of radiotherapy |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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