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

Prostate Cancer Metastatic Clinical Trial

— LoMP II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03655886
• Other study ID #: BC-01880
• Status: Recruiting
• Phase: Phase 2
• Start date: August 15, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male =18y

• Histologically proven PC

• Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy)

• 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

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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