The Impact of Continuous Versus Intermittent Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients: A Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 164
- 试验地点
- 10
- 主要终点
- Change of L-spine total BMD
研究概览
简要总结
Androgen deprivation therapy (ADT) is a mainstay of prostate cancer treatment to improve overall survival for intermediate- and high-risk localized disease as well as metastatic disease. While ADT improves survival, it can cause significant morbidity and a decrement in quality of life. In particular, ADT is associated with decrease in bone mineral density (BMD) and increased risk of fracture.
Although current guidelines recommend continuous androgen deprivation therapy (CAD) as standard therapy for high-risk disease, there has been increasing recognition of adverse effects from CAD. Since 1986, intermittent androgen deprivation therapy (IAD) as alternative therapeutic strategy for prostate cancer has been proposed to delay development of castration resistance and to reduce the side effects of ADT.
While both CAD and IAD are commonly used in real clinical practice, no prior study examined BMD change after CAD or IAD, and assessed whether bone loss would recover during off-treatment of IAD. The investigators therefore determine the rate of change in BMD induced by ADT (CAD versus IAD) in men with prostate cancer.
详细描述
Objective: To determine the rate of bone mass loss induced by two therapeutic strategies of ADT (CAD versus IAD) in men with prostate cancer.
Design, setting, and participants: the investigators will perform randomized, open label clinical trial. Men aged over 50 yrs old with prostate cancer (localized, locally advanced, metastatic prostate cancer) who are treated with primary ADT for newly diagnosed prostate cancer or salvage ADT at biochemical recurrence following radical prostatectomy will be included.
Participants will be randomly assigned to one of the following treatment arms:
Arm 1 (CAD): ADT without any discontinuation during study period (12 months).
Arm 2 (IAD): ADT for the first 6 months of study period, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged over 50 yrs old with histologically diagnosed prostate cancer (localized, locally advanced, metastatic prostate cancer) who are treated with primary ADT for newly diagnosed prostate cancer or salvage ADT at biochemical recurrence following radical prostatectomy. .
排除标准
- •men with double primary malignancies,
- •men who have been treated with ADT or other drug therapy such as denosumab, bisphosphonate or steroid,
- •men with osteoporosis at baseline (T-score ≤ -2.5),
- •men with a known bone disease,
- •men with poor performance status (i.e. Eastern Cooperative Oncology Group performance status 4),
- •men with life expectancy < 12 months,
- •men with increased serum PSA levels (≥ 4 ng/dL) or testosterone levels (≥ 50 ng/dL) even after 6 month ADT,
- •men who are not able to understand trial information or informed consent,
研究组 & 干预措施
Intermittent Androgen Deprivation
ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).
干预措施: Leuprorelin (Drug)
Intermittent Androgen Deprivation
ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).
干预措施: Goserelin (Drug)
Intermittent Androgen Deprivation
ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).
干预措施: Triptorelin (Drug)
Intermittent Androgen Deprivation
ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).
干预措施: Degarelix (Drug)
Intermittent Androgen Deprivation
ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).
干预措施: Bicalutamide (Drug)
Intermittent Androgen Deprivation
ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).
干预措施: Flutamide (Drug)
Intermittent Androgen Deprivation
ADT including luteinizing hormone-releasing hormone (LHRH) agonist and antagonist, antiandrogen, or maximum androgen blockade (MAB) should be withdrawn after 6 months of ADT, if the prostate-specific antigen (PSA) reaches its nadir (< 4 ng/dL) and serum testosterone reaches castration level (< 50 ng/dL).
干预措施: Maximum androgen blockade (Drug)
Continuous Androgen Deprivation
ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
干预措施: Leuprorelin (Drug)
Continuous Androgen Deprivation
ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
干预措施: Goserelin (Drug)
Continuous Androgen Deprivation
ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
干预措施: Triptorelin (Drug)
Continuous Androgen Deprivation
ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
干预措施: Degarelix (Drug)
Continuous Androgen Deprivation
ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
干预措施: Bicalutamide (Drug)
Continuous Androgen Deprivation
ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
干预措施: Flutamide (Drug)
Continuous Androgen Deprivation
ADT including LHRH agonist and antagonist, antiandrogen, or MAB without any discontinuation during study period.
干预措施: Maximum androgen blockade (Drug)
结局指标
主要结局
Change of L-spine total BMD
时间窗: At baseline and 12 months
Measured by bone densitometry
次要结局
- Osteoporosis(At 12 months)
- Change of femur neck BMD(At baseline and 12 months)
- Risk of 10 year major osteoporotic fracture(At 12 months)
- Quality of life after treatment(At baseline and 12 months)