Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostatic Neoplasms
- Sponsor
- University Hospital, Ghent
- Enrollment
- 80
- Locations
- 5
- Primary Endpoint
- Time to first Disease Related Event
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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). \[months\]
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. \[months\]
Secondary Outcomes
- Overall Survival(at year 1 - 2 - 5)
- Quality of Life(at month 6 - 12)
- Time to Androgen Deprivation Therapy start(up to 10 years, estimated to occur within 24 months)
- Prostate Cancer Specific Survival(at year 1 - 2 - 5)