The Impact of Local Treatment on Overall Survival in Patients with Metastatic Prostate Cancer on Diagnosis: A National Cancer Data Base Analysis.
Björn Löppenberg, Deepansh Dalela, Patrick Karabon...
https://pubmed.ncbi.nlm.nih.gov/27174537Actively Recruiting
Phase Not Applicable
Age: 18Years - 90Years
MALE
ID03129854
A Randomized Study of Androgen Deprivation Therapy Versus Androgen Deprivation Therapy Plus Prostate Cryotherapy in the Treatment of Patients With Primary Diagnosed Metastatic Prostate Cancer
Led by Sun Yat-sen University · Updated on 2019-06-07
250
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for men diagnosed with metastatic prostate cancer. The study compares standard continuous androgen deprivation therapy (ADT) alone to ADT combined with prostate cryotherapy. The goal is to assess progression-free survival, overall survival, cancer-specific survival, and health-related quality of life in these patients. Participants are randomly assigned to one of two groups: one receiving standard continuous ADT, and the other receiving ADT plus prostate cryotherapy within six months of starting ADT. This study does not involve masking or blinding and is sponsored by Sun Yat-sen University. Men in the trial will be followed until death or withdrawal from the study. Researchers will monitor disease progression and survival outcomes over an average period of 48 to 60 months. They will also assess quality of life using specific functional assessments. Participants undergo regular evaluations, including imaging scans and health assessments, to track treatment effects and safety throughout the study period.
CONDITIONS
Brief Title
Androgen Deprivation Therapy (ADT) Versus ADT Plus Prostate Cryotherapy for Metastatic Prostate Cancer (mPCa)
Who Can Participate
Age: 18Years - 90Years
MALE
Eligibility Criteria
You may qualify if you...
- Have histologically diagnosed prostate cancer
- Have metastatic disease diagnosed by CT scan, MRI scan, or bone scan with M stage M1a or M1b according to 2010 AJCC
- Be willing and able to provide written informed consent/assent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Overall mortality risk at 3 years less than 70%
- Time interval between hormonal therapy and randomization less than 6 months
- Can tolerate general anesthesia and cryosurgery
- Demonstrate adequate organ function
You will not qualify if you...
- Have serious illness or clinical conditions judged unsafe for the study by the doctor
- Infection grade 2 or higher per NCI-CTCAE version 4.03
- Heart failure NYHA class III or IV
- Crohn's disease or ulcerative colitis
- Fecal incontinence
- Substance abuse or medical, psychological, social problems interfering with study evaluation
- Any unstable disease or clinical condition posing safety risks or affecting compliance
- Other malignancies within 5 years except non-melanoma skin cancer
- Prostate cancer treatments other than hormonal therapy (except bisphosphonate 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months for prostate cryotherapy addition; ADT is continued as per standard care
Participants receive androgen deprivation therapy (ADT). Those in the experimental group also receive prostate cryotherapy within 6 months of starting ADT.
Visits scheduled according to treatment and monitoring needs
Follow-up
Duration - Up to 60 months
Participants are followed to monitor prostate cancer progression, overall survival, and functional outcomes.
Regular follow-up visits throughout the study period
Trial Site Locations
Total: 1 location
1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
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Research Team
Y
Yonghong Li, MD
Q
Qiuhong Chen, MD
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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Published Research Related To This Trial
Might men diagnosed with metastatic prostate cancer benefit from definitive treatment of the primary tumor? A SEER-based study.
Stephen H Culp, Paul F Schellhammer, Michael B Williams
https://pubmed.ncbi.nlm.nih.gov/24290503Best practice statement on cryosurgery for the treatment of localized prostate cancer.
Richard J Babaian, Bryan Donnelly, Duke Bahn...
https://pubmed.ncbi.nlm.nih.gov/18817934