Prostatic NeoplasmsLoMPNCT02138721
Local Treatment With RP for Newly-diagnosed mPCa
A study testing Radical Prostatectomy (RP) in people with Prostatic Neoplasms and Neoplasm Metastasis, run by University Hospital, Ghent at 5 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Neoplasm Metastasis
- What is being tested?
- Radical Prostatectomy (RP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesBelgium
- Study dates
- 28 Jun 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
Nicolaas Lumen, MD, PhD contact
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
ASZ Aalst
Aalst
- Recruiting
Imelda Ziekenhuis
Bonheiden
- Recruiting
University Hospital, Ghent
Ghent, 9000
- Recruiting
Sint-Fransiskusziekenhuis
Heusden-Zolder
- Recruiting
AZ Jan Portaels
Vilvoorde
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis
- Being tested
- Radical Prostatectomy (RP)
- Keywords
- Metastatic Prostate Cancer, Prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical Prostatectomy (RP)Procedure or surgery
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| No local treatment | No intervention | Routine care in metastatic prostate cancer. |
| Local treatment | Experimental | Radical Prostatectomy (RP) + routine care in metastatic prostate cancer. Receives: Procedure: Radical Prostatectomy (RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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]
Measured: up to 10 years
Secondary outcomes (4)
Overall Survival
From date of inclusion until the date of death from any cause, assessed up to 10 years. [months]
Measured: at year 1 - 2 - 5
Prostate Cancer Specific Survival
From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years. [months]
Measured: at year 1 - 2 - 5
Quality of Life
Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire
Measured: at month 6 - 12
Time to Androgen Deprivation Therapy start
From date of inclusion until the date of start of Androgen Deprivation Therapy (ADT) (criteria described in protocol) [months]
Measured: up to 10 years, estimated to occur within 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study start28 Jun 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolaas Lumen, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138721
- Sponsor's protocol ID
- B670201420709
- Acronym
- LoMP
- Status last verified
- Dec 2023
- First submitted
- 8 May 2014
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28435034
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).
- ClinicalTrials.gov ID
- NCT02138721
- Acronym / sponsor ID
- LoMP / B670201420709
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis
- Keywords
- Metastatic Prostate Cancer, Prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No local treatment | No intervention | –Routine care in metastatic prostate cancer. |
| Local treatment | Experimental | Procedure: Radical Prostatectomy (RP)Radical Prostatectomy (RP) + routine care in metastatic prostate cancer. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical Prostatectomy (RP)Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion. | Procedure or surgery | Local treatment |
Primary outcome
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]
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]
4 secondary outcomes
Overall Survival
Time frame: at year 1 - 2 - 5
Prostate Cancer Specific Survival
Time frame: at year 1 - 2 - 5
Quality of Life
Time frame: at month 6 - 12
Time to Androgen Deprivation Therapy start
Time frame: up to 10 years, estimated to occur within 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Results publication: PubMed 28435034Poelaert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaas Lumen, MD, PhD contact
Nicolaas Lumen, MD, PhD principal investigator
University Hospital, Ghent
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Prostatectomy (RP) in people with Prostatic Neoplasms and Neoplasm Metastasis, run by University Hospital, Ghent at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolaas Lumen, MD, PhD (nicolaas.lumen@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Castration Refractory Prostate Cancer Progression-Free Survival (time frame: up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02138721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.