NCT06824818招募中不适用
A Feasibility Trial of LHRH Agonist Discontinuation in Elderly Prostate Cancer Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- feasibility of stopping LHRH agonist therapy
研究概览
简要总结
This study seeks to identify if it is feasible to stop Luteinizing Hormone-Releasing Hormone (LHRH) Agonist Therapy in elderly men with prostate cancer. We hypothesize that elderly prostate cancer patients on long term androgen ablation with LHRH agonists will be permanently castrated and do not require ongoing LHRH agonist therapy. Participants will be monitored by testosterone testing throughout study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer with >3 years of LHRH agonist therapy.
- •Age ≥70 years.
- •ECOG performance status ≤2
- •Baseline testosterone of < 20 ng/ml
- •No prior chemotherapy or Lu-PSMA (unless survival predictions are favorable).
- •Ability to understand and sign informed consent.
排除标准
- 未提供
研究组 & 干预措施
discontinuation of LHRH agonist therapy in elderly prostate cancer patients
Experimental
干预措施: LHRH Agonist Therapy Discontinuation (Behavioral)
结局指标
主要结局
feasibility of stopping LHRH agonist therapy
时间窗: 12 months after discontinuing LHRH agonist therapy
Fraction of patients maintaining castrate testosterone levels
次要结局
- Patient interest in stopping treatment(End of enrollment (approximately 3 years after study start))
- Medication Impact(End of study (approximately 3 years after last participant is enrolled))
- Impact on Testosterone Levels (12 months)(12 months after last participant starts study)
- Impact on Testosterone Levels (36 months)(36 months after last participant starts study)
- Health Care Savings(End of study (approximately 3 years after last participant is enrolled))
- Visit Compliance(End of study (approximately 3 years after last participant is enrolled))
研究者
研究点 (2)
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