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

Study Overview
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Brief Summary
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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.

Detailed Description
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Ages Eligible for Study: 18 Years and older. Genders Eligible for Study: Male. Accepts Healthy Volunteers: No.

Official Title
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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

Conditions
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Prostate Cancer Metastatic

Intervention / Treatment
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* Device: prostate cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have histologically diagnosed prostate cancer Metastatic disease diagnosed by CT scan, MRI scan or bone scan. M stage M1a or M1b according to 2010 American joint Committee on Cancer (AJCC) stage system Be willing and able to provide written informed consent/assent for the trial Eastern Cooperative Oncology Group (ECOG) performance scale status of 0 or 1 Calculator of overall mortality risk at 3 years less than 70%( Eur Urol. 2016 May 9. pii: S0302-2838(16)30141-5. ) Time interval between hormonal therapy and randomization less than 6 months Can tolerate general anesthesia and cryosurgery Demonstrate adequate organ function Exclusion Criteria: According to the doctor's judgment, the patients had any serious illness or other clinical conditions, can't safely undergo the clinical research, any other serious diseases or clinical situation is not limited to the items listed below: Infection ≥ grade 2 according to National Cancer Institute on the common terminology criteria for adverse events (NCI-CTCAE) version 4.03, Heart failure (New York heart group NYHA) III or IV, Crohn's disease or ulcerative colitis, Fecal incontinence, Substance abuse, medical, psychological or social problems that may interfere with the evaluation of the results of this study, The presence of any unstable disease or clinical condition, potential harm to the safety of the subject or influence the subject's compliance. Other malignancies (within 5 years), except for non melanoma skin cancer. Patients with other malignancies who survived with effective treatment and randomized to have no evidence of cancer for more than 5 years were allowed to participate in the study Treatment of prostate cancer other than hormonal therapy (except bisphosphonate therapy for bone metastases) After 6 months of hormonal treatment, the prostate volume greater than 55ml

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Prostate cryotherapy plus ADT | Device: prostate cryotherapy<br>* prostate cryotherapy added to experimental group within 6 months of ADT<br>* Other names: prostate cryoablation;|
| No Intervention: control group<br>standard of care ADT continually | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Cancer Progression-Free Survival | Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer | through study completion, an average of 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall Survival (OS), from beginning of ADT to death | through study completion, an average of 60 months | 
| prostate cancer specific survival | prostate cancer specific survival (CSS), from beginning of ADT to death from prostate cancer | through study completion, an average of 60 months | 
| Functional Assessment of Cancer Therapy-Prostate | Functional Assessment of Cancer Therapy-Prostate (FACT-P), From beginning of ADT to death | through study completion, an average of 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADT, prostate cancer, metastatic, cryotherapy