NCT03655886

Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation As a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
PROCEDURE	radical prostatectomy	can be performed either open, laparoscopic or robot-assisted, which is chosen by the discretion and expertise of the performing surgeon
RADIATION	Whole pelvis radiotherapy	radiation of prostate bed and pelvis

Timeline

• Start date: 2018-08-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-08-31
• Last updated: 2025-03-21

Locations

6 sites across 1 country: Belgium