Actively Recruiting
Androgen Deprivation Therapy (ADT) Versus ADT Plus Prostate Cryotherapy for Metastatic Prostate Cancer (mPCa)
Led by Sun Yat-sen University · Updated on 2019-06-07
250
Participants Needed
1
Research Sites
482 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with primary diagnosed metastatic prostate cancer are randomly divided into two groups. One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy. Patients are followed up until their death or withdraw from this study due to other reasons. The primary endpoint of this study is prostate cancer Progression-Free Survival. The secondary endpoint is overall survival, prostate cancer specific survival and health-related quality of life.
CONDITIONS
Official Title
Androgen Deprivation Therapy (ADT) Versus ADT Plus Prostate Cryotherapy for Metastatic Prostate Cancer (mPCa)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically diagnosed prostate cancer
- Metastatic disease confirmed by CT, MRI, or bone scan (M stage M1a or M1b by 2010 AJCC system)
- Able and willing to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Overall mortality risk at 3 years less than 70%
- Hormonal therapy started less than 6 months before randomization
- Able to tolerate general anesthesia and cryosurgery
- Adequate organ function
You will not qualify if you...
- Serious illness or clinical condition preventing safe participation as judged by doctor
- Infection grade 2 or higher by NCI-CTCAE version 4.03
- Heart failure NYHA class III or IV
- Crohn's disease or ulcerative colitis
- Fecal incontinence
- Substance abuse, psychological, medical, or social issues interfering with study evaluation
- Any unstable disease or condition threatening safety or compliance
- Other cancers within 5 years except non-melanoma skin cancer unless cancer-free for over 5 years
- Prostate cancer treatment other than hormonal therapy (except bisphosphonates for bone metastases)
- Prostate volume greater than 55 ml after 6 months of hormonal treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yonghong Li, MD
CONTACT
Q
Qiuhong Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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