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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    250
  • sponsor
    Sun Yat-sen University
Updated on 25 February 2022
ct scan
androgens
endocrine therapy
metastasis
hormone therapy
antiandrogen therapy
bone scan
androgen ablation

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.

Description

Ages Eligible for Study: 18 Years and older.

Genders Eligible for Study: Male.

Accepts Healthy Volunteers: No.

Details
Condition Prostate Cancer Metastatic
Treatment prostate cryotherapy
Clinical Study IdentifierNCT03129854
SponsorSun Yat-sen University
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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
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