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

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.

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.

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]

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]

From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years. [months]

From date of inclusion until the date of start of Androgen Deprivation Therapy (ADT) (criteria described in protocol) [months]

Tumor burden assessment will be performed by image-based evaluation (RECIST criteria v1.1) when possible.

Evaluation of cost [€] and quality-adjusted life years [QALYs] related to interventions needed in both arms from inclusion to death.

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

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.