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

Primary Purpose

Prostate Cancer Metastatic

Status

Recruiting

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

radical prostatectomy

Whole pelvis radiotherapy

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring metastatic, prostate cancer, local, cytoreductive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University Hospital GhentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Radical prostatectomy

Radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03655886

First Posted

July 26, 2018

Last Updated

December 16, 2022

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT03655886

Brief Title

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

Acronym

LoMP II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 15, 2018 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer Metastatic

Keywords

metastatic, prostate cancer, local, cytoreductive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radical prostatectomy

Arm Type

Experimental

Arm Title

Radiotherapy

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

radical prostatectomy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Whole pelvis radiotherapy

Intervention Description

radiation of prostate bed and pelvis

Primary Outcome Measure Information:

Title

Feasibility of randomization between both treatment arms as assessed by the randomized proportion

Description

Time Frame

48 months

Secondary Outcome Measure Information:

Title

castration-resistant free survival

Description

Calculated starting from date of randomization until castration-resistant disease development, as defined by the European Association of Urology (EAU) guidelines

Time Frame

48 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolaas Lumen, PhD

Phone

+3293322276

poli.urologie@uzgent.be

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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