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

Send

Updated on 25 February 2022

See if I qualify

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 Identifier	NCT03129854
Sponsor	Sun Yat-sen University
Last Modified on	25 February 2022

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