An open randomized, multicenter, controlled study of androgen deprivation therapy with or without prostate cryoablation in treating patients with newly diagnosed metastatic prostate cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-16008237

Enrollment

Unknown

Registered

2016-04-07

Start date

2016-04-11

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

1:Hormonal therapy

2:Hormonal therapy with cryoablation

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. male 2. To be aged 18 Years old or oldder 3. Histologically confirmed prostate adenocarcinoma; 4. Through the bone scan, CT and / or MR examination, according to the standard diagnosis of AJCC (American joint Committee on Cancer) in 2010 was M1b, and the number of bone lesions was less than 5; 5. For newly diagnosed hormone treatment sensitizes prostate cancer, received androgen-deprivation therapy and PSA decreased to less than 4ng/ml within 6 months, serum testosterone concentration lower than 50 ng/dL or <1.7 nmol/L, metastatic lesions disappeared or stability, no new lymph node metastasis and abdominal viscera metastasis; 6. From the start of androgen deprivation therapy to random group time is less than 6 months; 7. ECOG performance status (PS) 0-1; 8. Life expectance longer than 2 years; 9. Subjects volunteered to participate and signed informed consent; 10. Patients can tolerate general anesthesia and prostate cryoablation surgery. 11. adequate hepatic, haematological, cardiac, renal and other function, the laboratory test meeting any of the following criteria: ALT and AST less than or equal to 2.5 times ULN, serum creatinine (CRE) less than or equal to 1.5 x ULN, neutrophil count more than 1.5*10^9/L, hemoglobin more than 90g/dL , platelet count more than 80*10^9/L, ECG showed no obvious abnormality, or abnormal no clinical significance.

Exclusion criteria

Exclusion criteria: 1. According to the doctor's judgment, patients with mental disorders or other physical disease, can not safely accept the clinical research treatment program; 2. The presence of visceral metastases; 3. The number of bone metastases was more than 4; 4. Patients with lymph node metastases outside the pelvic region; 5. Small cell carcinoma of the prostate; 6. Patients with other local treatment of prostate or clinical trials; 7. The volume of prostate was still greater than 55ml after androgen-deprivation therapy for 6 months.

Design outcomes

Primary

Measure	Time frame
Progression free survival;	—

Secondary

Measure	Time frame
overall survival;Prostate cancer specific survival time;HRQOL;	—

Countries

China

Contacts

Public ContactFangjian Zhou

Sun Yat-sen University Cancer Center

zhoufj@sysucc.org.cn+86 028 7343312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026