Prostate Cancer Metastatic
Conditions
Keywords
oligometastasis, prostate cancer, radical prostatectomy, progression-free survival, quality of life
Brief summary
This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.
Detailed description
In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.
Interventions
PROCEDURERadical prostatectomy plus standard care
To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer
DRUGStandard of care for metastatic prostate cancer
androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer
Sponsors
University College, London
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants is willing and able to give informed consent for participation in the study * Male aged 19-75 years. * Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases). * Locally resectable tumor (clinical/radiological stage T1-T3). * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Suitable for radical prostatectomy within 12 months of starting standard care.
Exclusion criteria
* Contraindications to radical prostatectomy. * Visceral metastases. * Prior radiotherapy to the abdomen/pelvis or to skeletal metastases. * Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment. * Current involvement in other interventional research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the time to castrate resistance | 36 months after randomization | The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life in patients post-randomization | three month post randomization | EuroQOL 5 dimensions 5 levels (EQ-5D-5L) questionnaire will be used to assess quality of life in patients after randomization with different treatments. This is designed to measure health-related quality of life. It consists of a questionnaire and a visual analogue scale. The subjects in 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression are asked to grade their own current level of function in each dimension into one of five levels of disability (i.e. I have no problems waling about, slight problems, moderate problems, severe problems, or unable to walk). This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable. |
Countries
China
Contacts
Primary ContactJian-Ming Guo, MD, PhD
Backup ContactLei Xu, MD, PhD
Outcome results
None listed