Neoplasm Metastasis, Prostatic Neoplasms
Conditions
Keywords
Metastatic Prostate Cancer, Prostatectomy
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.
Interventions
PROCEDURERadical Prostatectomy (RP)
Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.
Sponsors
University Hospital, Ghent
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Castration Refractory Prostate Cancer Progression-Free Survival | 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 | 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). \[months\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer Specific Survival | at year 1 - 2 - 5 | From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years. \[months\] |
| Time to Androgen Deprivation Therapy start | up to 10 years, estimated to occur within 24 months | From date of inclusion until the date of start of Androgen Deprivation Therapy (ADT) (criteria described in protocol) \[months\] |
| Quality of Life | at month 6 - 12 | Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire |
| Overall Survival | at year 1 - 2 - 5 | From date of inclusion until the date of death from any cause, assessed up to 10 years. \[months\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cytoreductive effect of local treatment in metastatic disease lesions [%] | at month 3 - 6 | Tumor burden assessment will be performed by image-based evaluation (RECIST criteria v1.1) when possible. |
| Cost-effectiveness of local treatment arm versus no local treatment arm | analysis after trial ending, estimated in 10-15 years | Evaluation of cost \[€\] and quality-adjusted life years \[QALYs\] related to interventions needed in both arms from inclusion to death. |
Countries
Belgium
Contacts
Primary ContactNicolaas Lumen, MD, PhD
Outcome results
None listed