Local Treatment With RP for Newly-diagnosed mPCa (LoMP)

December 19, 2023 updated by: University Hospital, Ghent

Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).

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.

Study Overview

Status

Recruiting

Detailed Description

Patients recently diagnosed with metastatic prostate cancer (mPCa), and meeting the eligibility criteria, will be given the opportunity to enroll in this study.

Study Groups:

After inclusion, patients requesting local treatment can undergo radical prostatectomy (RP) with pelvic lymph-node dissection (PLND) after multi-disciplinary evaluation. This resulting in a local treatment group and a no local treatment group. For ethical reasons, no randomization will be done.

Follow-up:

Patients not undergoing local treatment will undergo the current standard of care in our institution. And besides the intervention of local treatment, the other patients will receive this same current standard of care.

Routine follow-up visits, with physical examination, laboratory tests and questionnaires, will be scheduled every 3 months. A CT-scan (abdomen-pelvis) and bone scan will be performed if a clinical progression is diagnosed or suspected and when Castration Refractory PCa (CRPC) is established.

Androgen Deprivation Therapy (ADT) will be initiated in case of one of the following:

  • symptoms related to metastatic lesion(s)
  • Prostate Specific Antigen (PSA) > 50ng/ml and doubling time (PSA-DT) < 6 months (starting 3 months after inclusion at earliest)

The estimated number of patients to be included in the local treatment arm is 40.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Aalst, Belgium
        • Recruiting
        • ASZ Aalst
      • Bonheiden, Belgium
        • Recruiting
        • Imelda Ziekenhuis
      • Ghent, Belgium, 9000
        • Recruiting
        • University Hospital, Ghent
      • Heusden-Zolder, Belgium
        • Recruiting
        • Sint-Fransiskusziekenhuis
      • Vilvoorde, Belgium
        • Recruiting
        • AZ Jan Portaels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No local treatment
Routine care in metastatic prostate cancer.
Experimental: Local treatment
Radical Prostatectomy (RP) + routine care in metastatic prostate cancer.
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Castration Refractory Prostate Cancer Progression-Free Survival
Time Frame: up to 10 years
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
Time Frame: up to 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: at year 1 - 2 - 5
From date of inclusion until the date of death from any cause, assessed up to 10 years. [months]
at year 1 - 2 - 5
Prostate Cancer Specific Survival
Time Frame: at year 1 - 2 - 5
From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years. [months]
at year 1 - 2 - 5
Quality of Life
Time Frame: at month 6 - 12
Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire
at month 6 - 12
Time to Androgen Deprivation Therapy start
Time Frame: up to 10 years, estimated to occur within 24 months
From date of inclusion until the date of start of Androgen Deprivation Therapy (ADT) (criteria described in protocol) [months]
up to 10 years, estimated to occur within 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytoreductive effect of local treatment in metastatic disease lesions [%]
Time Frame: at month 3 - 6
Tumor burden assessment will be performed by image-based evaluation (RECIST criteria v1.1) when possible.
at month 3 - 6
Cost-effectiveness of local treatment arm versus no local treatment arm
Time Frame: analysis after trial ending, estimated in 10-15 years
Evaluation of cost [€] and quality-adjusted life years [QALYs] related to interventions needed in both arms from inclusion to death.
analysis after trial ending, estimated in 10-15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicolaas Lumen, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimated)

May 15, 2014

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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