Zhongshan Hospital, Fudan University
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Fudan University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- the time to castrate resistance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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-
- •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.
Arms & Interventions
Intervention Group
Radical prostatectomy plus standard care
Intervention: Radical prostatectomy plus standard care (Procedure)
Intervention Group
Radical prostatectomy plus standard care
Intervention: Standard of care for metastatic prostate cancer (Drug)
Comparator Group
Standard care, currently ADT +/- other systemic therapies.
Intervention: Standard of care for metastatic prostate cancer (Drug)
Outcomes
Primary Outcomes
the time to castrate resistance
Time Frame: 36 months after randomization
The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.
Secondary Outcomes
- Quality of life in patients post-randomization(three month post randomization)
Investigators
Jianming Guo
Professor
Fudan University