Local Treatment With RP for Newly-diagnosed mPCa

Prostatic Neoplasms Clinical Trial

— LoMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02138721
• Other study ID #: B670201420709
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Nicolaas Lumen, MD, PhD
• Email: nicolaas.lumen[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	University Hospital, Ghent	Ghent
Belgium	Sint-Fransiskusziekenhuis	Heusden-Zolder
Belgium	AZ Jan Portaels	Vilvoorde

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

References & 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 Metastat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cytoreductive effect of local treatment in metastatic disease lesions [%]	Tumor burden assessment will be performed by image-based evaluation (RECIST criteria v1.1) when possible.	at month 3 - 6
Other	Cost-effectiveness of local treatment arm versus no local treatment arm	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
Primary	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
Primary	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	Overall Survival	From date of inclusion until the date of death from any cause, assessed up to 10 years. [months]	at year 1 - 2 - 5
Secondary	Prostate Cancer Specific Survival	From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years. [months]	at year 1 - 2 - 5
Secondary	Quality of Life	Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire	at month 6 - 12
Secondary	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]	up to 10 years, estimated to occur within 24 months