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

Sun Yat-sen University

Status

Enrolling

Conditions

Prostate Cancer Metastatic

Treatments

Device: prostate cryotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03129854

YoLi

Details and patient eligibility

About

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.

Full description

Ages Eligible for Study: 18 Years and older.

Genders Eligible for Study: Male.

Accepts Healthy Volunteers: No.

Enrollment

250 estimated patients

Sex

Male

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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