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

NCT03655886 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-03-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655886 on ClinicalTrials.gov