Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02138721
Recruitment Status : Unknown
Verified May 2017 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : May 15, 2014
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Neoplasm Metastasis Procedure: Radical Prostatectomy (RP) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).
Study Start Date : May 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.
Procedure: Radical Prostatectomy (RP)
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.




Primary Outcome Measures :
  1. 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]

  2. 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]


Secondary Outcome Measures :
  1. 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]

  2. 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]

  3. Quality of Life [ Time Frame: at month 6 - 12 ]
    Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire

  4. 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]


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138721


Contacts
Layout table for location contacts
Contact: Nicolaas Lumen, MD, PhD nicolaas.lumen@uzgent.be

Locations
Layout table for location information
Belgium
ASZ Aalst Recruiting
Aalst, Belgium
Imelda Ziekenhuis Recruiting
Bonheiden, Belgium
University Hospital, Ghent Recruiting
Ghent, Belgium, 9000
Sint-Fransiskusziekenhuis Recruiting
Heusden-Zolder, Belgium
AZ Jan Portaels Recruiting
Vilvoorde, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Layout table for investigator information
Principal Investigator: Nicolaas Lumen, MD, PhD University Hospital, Ghent

Publications of Results:
Layout table for additonal information
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02138721     History of Changes
Other Study ID Numbers: B670201420709
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Ghent:
Metastatic Prostate Cancer
Prostatectomy

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes