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According to the guidelines of the European Association of Urology (EAU), the first-line treatment for newly diagnosed mPC consists of immediate castration with the addition of docetaxel or abiraterone acetate. As seen in other well-known solid tumours - such as ovarian, colon and renal cancer - local treatment (LT) of the primary tumour could lead to a survival benefit compared to standard of care (SOC). Several retrospective studies have suggested a survival benefit of local treatment of the primary tumour with SOC versus SOC only in mPC. These patients also have less local symptoms of their disease, which has a major impact on quality of life (QoL). Several prospective studies have already been set up to compare either surgery or radiotherapy with the SOC. In expectation of their results and because randomization seems challenging, the investigators want to set up a trial to evaluate the feasibility of randomization between both local treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical prostatectomy | Experimental |
| |
| Radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radical prostatectomy | Procedure | can be performed either open, laparoscopic or robot-assisted, which is chosen by the discretion and expertise of the performing surgeon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of randomization between both treatment arms as assessed by the randomized proportion | In this trial we want to assess whether it is feasible to randomize patients into both treatment arms. All patients eligible for inclusion will be reported. The eventual proportion of randomized patients will be evaluated. Reasons for exclusion will be monitored. | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic progression-free survival | Calculated starting from date of randomization to radiographic progression or death from any cause whichever occurred first | 48 months |
| Clinical progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Castration-resistant free survival | Calculated starting from date of randomization until castration-resistant disease development, as defined by the European Association of Urology (EAU) guidelines | 48 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerp | 2650 | Belgium | ||
| AZ Jan Palfijn |
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| Whole pelvis radiotherapy | Radiation | radiation of prostate bed and pelvis |
|
Calculated starting from date of randomization to the date of radiographic progression, symptoms, initiation of new treatment, or death, whichever occurred first.
| 48 months |
| Quality of life (QLQ-C30 + QLQ-PR25) | Evaluation of quality of life will be done using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire, extended by the QLQ-PR25. | 48 months |
| Acute and late toxicity due to local treatment | Early complications after radical prosatatectomy will be evaluated using the Clavien-Dindo classification for surgical complications. Acute and late toxicity after radiotherapy will be evaluated using the Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). This outcome will be assessed descriptively, as a direct comparison between the two toxicity classifications would be inappropriate. | 48 months |
| Ghent |
| East Flanders |
| 9000 |
| Belgium |
| Leuven University Hospital | Leuven | Flemish Brabant | 3000 | Belgium |
| AZ Maria Middelares | Ghent | Ghent | 9000 | Belgium |
| AZ Sint-Jan | Bruges | West Flanders | 8000 | Belgium |
| University Hospital Ghent | Ghent | Belgium |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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