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

Sun Yat-sen University1 site in 1 country250 target enrollmentMarch 29, 2017

ConditionsProstate Cancer Metastatic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer Metastatic
Sponsor: Sun Yat-sen University
Enrollment: 250
Locations: 1
Primary Endpoint: Prostate Cancer Progression-Free Survival
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

March 29, 2017

End Date

June 30, 2026

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Yonghong Li

Principal Investigator

Sun Yat-sen University

Eligibility Criteria

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
•pii: S0302-2838(16)30141-
•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

Outcomes

Primary Outcomes

Prostate Cancer Progression-Free Survival

Time Frame: through study completion, an average of 48 months

Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer

Secondary Outcomes

prostate cancer specific survival(through study completion, an average of 60 months)
Overall Survival(through study completion, an average of 60 months)
Functional Assessment of Cancer Therapy-Prostate(through study completion, an average of 48 months)