RecruitingNot ApplicableNCT03129854

Androgen Deprivation Therapy (ADT) Versus ADT Plus Prostate Cryotherapy for Metastatic Prostate Cancer (mPCa)

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

Sponsor

Sun Yat-sen University

Enrollment

250 participants

Start Date

Mar 29, 2017

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Metastatic

Summary

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether adding a freezing treatment (cryotherapy) to the prostate — on top of standard hormone therapy — helps men live longer with metastatic prostate cancer (cancer that has spread beyond the prostate). **You may be eligible if...** - You have been diagnosed with prostate cancer that has spread to lymph nodes or bones (confirmed by CT, MRI, or bone scan) - Your overall health and functioning are good (meaning you can carry out normal daily activities) - Your estimated 3-year survival risk is less than 70% based on a specific calculator - You are willing and able to provide written consent **You may NOT be eligible if...** - Your prostate cancer has not spread to other parts of the body - Your health is too poor to undergo cryotherapy - Your estimated survival risk is 70% or higher at 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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