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

NCT ID: NCT03655886

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radical prostatectomy

Group Type: EXPERIMENTAL

radical prostatectomy

Intervention Type: PROCEDURE

can be performed either open, laparoscopic or robot-assisted, which is chosen by the discretion and expertise of the performing surgeon

Radiotherapy

Group Type: EXPERIMENTAL

Whole pelvis radiotherapy

Intervention Type: RADIATION

radiation of prostate bed and pelvis

Interventions

radical prostatectomy

can be performed either open, laparoscopic or robot-assisted, which is chosen by the discretion and expertise of the performing surgeon

Intervention Type: PROCEDURE

Whole pelvis radiotherapy

radiation of prostate bed and pelvis

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Male ≥18y
• Histologically proven PC
• Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy) or PSMA PET-CT
• ECOG 0-1 (2 if related to local PC symptoms)
• Eligible for local treatment
• Written informed consent and able and willing to comply with protocol requirements

Exclusion Criteria

• Previous systemic treatment for PC except ADT started within 3 months before randomization
• Previous radiotherapy to the pelvis interfering with prostate irradiation
• Previous surgery in the pelvis interfering with radical prostatectomy
• Symptoms related to metastatic lesions, persisting for at least 2 weeks after initiation of ADT
• Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
• Previous or current malignant disease which is likely to interfere with LoMP II treatment or assessment
• Psychological disorder intervening with understanding the information or the informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

AZ Jan Palfijn

Ghent, East Flanders, Belgium

Leuven University Hospital

Leuven, Flemish Brabant, Belgium

AZ Maria Middelares

Ghent, Ghent, Belgium

AZ Sint-Jan

Bruges, West Flanders, Belgium

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

Other Identifiers

BC-01880

Identifier Type: -

Identifier Source: org_study_id