Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy for High-Risk Localized Prostate Cancer - Open-Label Randomized Clinical Study
试验速览
- 阶段
- 3 期
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- A composite trifecta endpoint of treatment failure at 3 years after cryoablation
研究概览
简要总结
This is an open-label randomized clinical study comparing primary prostate cryoablation alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.
详细描述
Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT (Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive ADT for a total of 12 months. PSA will be checked every 3 months in the first year after Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician thinks it necessary to document tumor recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age>20 years
- •Histopathology proven prostate adenocarcinoma
- •Non-metastatic localized disease
- •Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or clinical staging>=T2c)
- •Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
- •Subjects who have not been treated with any definitive treatments for prostate cancer, including radical prostatectomy or definitive radiotherapy. However, those who have undergone focal prostate cryoablation and have cancer recurrence are still eligible.
- •Subjects may or may not have received neoadjuvant androgen-deprivation therapy (ADT) in the forms of either castration (medical) and/or antiandrogens. Surgical castration (orchiectomy) is not allowed.
- •Subjects are willing to sign the informed consent and agree to comply with the study procedures
排除标准
- •Those who have been treated with > 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
- •Subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin
- •Other conditions the investigators think may affect subject compliance or safety
研究组 & 干预措施
Adjuvant Androgen-Deprivation Therapy
Cryotherapy with Short-term Adjuvant Androgen-Deprivation Therapy
干预措施: Adjuvant Androgen-Deprivation Therapy (Drug)
结局指标
主要结局
A composite trifecta endpoint of treatment failure at 3 years after cryoablation
时间窗: 3 years
A composite trifecta endpoint of treatment failure at 3 years after cryoablation defined by either of the three, biochemical (PSA) recurrence (by the Phoenix criteria) or biopsy-proven recurrence or initiation of hormone therapy for disease recurrence whichever comes first.
次要结局
- Time to the composite endpoint of treatment failure since cryoablation(3 years)
- Biochemical (PSA) recurrence-free survival(3 years)
- Biochemical (PSA) recurrence rate at 3 years(3 years)
- Biopsy-proven recurrence rate at 3 years(3 years)
- Biopsy-proven recurrence-free survival(3 years)
- Safety profile(3 years)