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

NCT03655886 | Completed Phase 2

• 1 other identifier: BC-01880
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 6

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

Keywords

metastatic; prostate cancer; local; cytoreductive

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Radiographic progression-free survival

  48 months

• Clinical progression-free survival

  48 months

• Quality of life (QLQ-C30 + QLQ-PR25)

  48 months

• Acute and late toxicity due to local treatment

  48 months

Other Outcomes (1)

• Castration-resistant free survival

  48 months

Study Arms (2)

Radical prostatectomy

EXPERIMENTAL

Procedure: radical prostatectomy

Radiotherapy

EXPERIMENTAL

Radiation: Whole pelvis radiotherapy

Interventions

radical prostatectomy PROCEDURE

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

Radical prostatectomy

Whole pelvis radiotherapy RADIATION

radiation of prostate bed and pelvis

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (6)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

AZ Jan Palfijn

Ghent, East Flanders, 9000, Belgium

Location

Leuven University Hospital

Leuven, Flemish Brabant, 3000, Belgium

Location

AZ Maria Middelares

Ghent, Ghent, 9000, Belgium

Location

AZ Sint-Jan

Bruges, West Flanders, 8000, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 31, 2018
• Study Start: August 15, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

BE (6)