DUET-study: A FEASIBILITY STUDY OF 177LU-PSMA RADIOLIGAND THERAPY ALTERNATED WITH RADIUM-223 IN PATIENTS WITH BONE-METASTATIC, OLIGO-METASTATIC HORMONE-SENSITIVE PROSTATE CANCER AFTER CURATIVE THERAPY.
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The feasibility and safety of drug application in patients with bone metastatic, oligometastatic, HSPCa after curative therapy (i.e., radical prostatectomy) treated by alternated Radium-223 RLT and 177Lu-PSMA RLT.
研究概览
简要总结
The primary objective of this study is to assess the feasibility and safety of drug application in patients with bone metastatic, oligometastatic, hormone sensitive prostate cancer after curative therapy treated by Radium-223 radioligand therapy (RLT) alternated with 177Lu-PSMA RLT.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- -
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological proven adenocarcinoma of the prostate
- •Patients must have a life expectancy >12 months
- •Laboratory values (at baseline within 4 weeks before start of therapy ): • White blood cells > 4.0 x 109/l • Platelet count > 150 x 109/l • Hemoglobin > 7.0 mmol/l • MDRD‐GFR ≥ 60 ml/min
- •Signed informed consent.
- •Previous curative therapy with a radical prostatectomy or external-beam radiotherapy (EBRT)
- •Biochemical recurrence
- •Serum PSA progression
- •PSMA expressing metastases on an 18F‐PSMA‐PET‐CT scan: bone (and/or lymph node metastases) (miN1/miM1ab): minimally 1 bone metastases, maximally 5 bone metastases
- •Local treatment for oligo‐metastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions or if the patient refuses these treatments)
- •No prior hormonal therapy (including any androgen directed treatment such as finasteride, dutasteride, bicalutamide, apalutamide, abiraterone, enzalutamide, and darolutamide) or taxane based chemotherapy (docetaxel or cabazitaxel)
- •Testosterone > 1.7 nmol/l (at baseline within 4 weeks before start of therapy)
- •A detectable lesion on the 18F‐PSMA PET/CT (at baseline within 4 weeks before start of therapy)
排除标准
- •A known subtype other than prostate adenocarcinoma
- •Previous radioligand treatment
- •Visceral (liver/lung) or brain metastases
- •Any medical condition that in the opinion of the investigator will negatively affect patients’ clinical status when participating in this trial
- •Prior hip replacement surgery potentially influencing performance of PSMA PET/CT
- •Sjögrens syndrome
- •A second active malignancy other than prostate cancer
结局指标
主要结局
The feasibility and safety of drug application in patients with bone metastatic, oligometastatic, HSPCa after curative therapy (i.e., radical prostatectomy) treated by alternated Radium-223 RLT and 177Lu-PSMA RLT.
The feasibility and safety of drug application in patients with bone metastatic, oligometastatic, HSPCa after curative therapy (i.e., radical prostatectomy) treated by alternated Radium-223 RLT and 177Lu-PSMA RLT.
The proposed treatment schedule is considered unfeasible when treatment is postponed more than 4 weeks in more than 50% of participants due to treatment related toxicity (myelosuppression or xerostomia), or when treatment had to be cancelled due to unwillingness of patients to continue (or complete) treatment.
The proposed treatment schedule is considered unfeasible when treatment is postponed more than 4 weeks in more than 50% of participants due to treatment related toxicity (myelosuppression or xerostomia), or when treatment had to be cancelled due to unwillingness of patients to continue (or complete) treatment.
次要结局
- The tolerability (toxicity) of study medication (i.e., Ra-223 RLT and 177Lu-PSMA RLT)
- the health-related quality of life (HRQoL) and the incidence of xerostomia by patient reported outcome measures (PROMS) using the RAND-36 and the xerostomia inventory, at baseline and repeatedly each two weeks after initiation of 177Lu-PSMA RLT and after the last treatment.
- the prostate-specific antigen (PSA) free survival at 3,6 and 12 months after combined cytotoxic RLT, i.e., 177Lu-PSMA RLT and Radium-223 RLT.
- the radiological response on PSMA PET/CT, bone scan and CT abdomen and thorax performed three months after last treatment (± 3 weeks).
研究者
Investigator
Scientific
Amsterdam UMC Stichting