NCT02138721

Brief Summary

The objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
4.1 years until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

6.5 years

First QC Date

May 8, 2014

Last Update Submit

December 19, 2023

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Keywords

Metastatic Prostate CancerProstatectomy

Outcome Measures

Primary Outcomes (2)

  • Castration Refractory Prostate Cancer Progression-Free Survival

    From date of inclusion until the date of Castration Refractory Prostate Cancer (CRPC) defined according to European Association of Urology (EAU) guidelines, or date of death from any cause, whichever came first, assessed up to 10 years. \[months\]

    up to 10 years

  • Time to first Disease Related Event

    From date of inclusion until the date of any event related to local disease progression (eg ureter obstruction, bladder outlet obstruction), any Skeletal Related Event (SRE) or any event related to metastasis (eg lymphedema). \[months\]

    up to 10 years

Secondary Outcomes (4)

  • Overall Survival

    at year 1 - 2 - 5

  • Prostate Cancer Specific Survival

    at year 1 - 2 - 5

  • Quality of Life

    at month 6 - 12

  • Time to Androgen Deprivation Therapy start

    up to 10 years, estimated to occur within 24 months

Other Outcomes (2)

  • Cytoreductive effect of local treatment in metastatic disease lesions [%]

    at month 3 - 6

  • Cost-effectiveness of local treatment arm versus no local treatment arm

    analysis after trial ending, estimated in 10-15 years

Study Arms (2)

No local treatment

NO INTERVENTION

Routine care in metastatic prostate cancer.

Local treatment

EXPERIMENTAL

Radical Prostatectomy (RP) + routine care in metastatic prostate cancer.

Procedure: Radical Prostatectomy (RP)

Interventions

Radical Prostatectomy (RP)PROCEDURE

Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.

Local treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of prostate adenocarcinoma, confirmed by histology
  • Newly diagnosis of metastatic disease (stage TanyNanyM+)
  • Life expectancy ≥2y based on comorbid conditions, WHO performance status 0-2
  • Written informed consent, male ≥18yo
  • Willing and expected to comply with study protocol and follow-up schedule
  • Multidisciplinary Oncologic Consultation (MOC) approval

You may not qualify if:

  • Previous local or systemic treatment for prostate cancer
  • Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
  • Symptoms clearly related to metastatic lesions
  • Any other previous or current (malignant) disease which, in the judgment of the responsible physician, is likely to interfere with LoMP treatment or assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

ASZ Aalst

Aalst, Belgium

RECRUITING

Imelda Ziekenhuis

Bonheiden, Belgium

RECRUITING

University Hospital, Ghent

Ghent, 9000, Belgium

RECRUITING

Sint-Fransiskusziekenhuis

Heusden-Zolder, Belgium

RECRUITING

AZ Jan Portaels

Vilvoorde, Belgium

RECRUITING

Related Publications (1)

  • Poelaert F, Verbaeys C, Rappe B, Kimpe B, Billiet I, Plancke H, Decaestecker K, Fonteyne V, Buelens S, Lumen N. Cytoreductive Prostatectomy for Metastatic Prostate Cancer: First Lessons Learned From the Multicentric Prospective Local Treatment of Metastatic Prostate Cancer (LoMP) Trial. Urology. 2017 Aug;106:146-152. doi: 10.1016/j.urology.2017.02.051. Epub 2017 Apr 20.

    PMID: 28435034RESULT

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolaas Lumen, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolaas Lumen, MD, PhD

CONTACT

nicolaas.lumen@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 15, 2014

Study Start

June 28, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

BE(5)