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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.
ASZ Aalst
Aalst, Belgium
RECRUITINGImelda Ziekenhuis
Bonheiden, Belgium
RECRUITINGUniversity Hospital, Ghent
Ghent, Belgium
RECRUITINGCastration 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. \[months\]
Time frame: 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). \[months\]
Time frame: up to 10 years
Overall Survival
From date of inclusion until the date of death from any cause, assessed up to 10 years. \[months\]
Time frame: 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. \[months\]
Time frame: at year 1 - 2 - 5
Quality of Life
Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire
Time frame: 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) \[months\]
Time frame: up to 10 years, estimated to occur within 24 months
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Sint-Fransiskusziekenhuis
Heusden-Zolder, Belgium
RECRUITINGAZ Jan Portaels
Vilvoorde, Belgium
RECRUITING