NL-OMON56209尚未招募不适用
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. THE DUET STUDY - DUET trial
Amsterdam UMC0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histological proven adenocarcinoma of the prostate
- •- Previous radical prostatectomy
- •- Biochemical recurrence (PSA > 0.5 µg/l).
- •- PSA*doubling time < 6 months. Serum PSA progression is defined as 2
- •consecutive rising PSA
- •values measured at least 1 week apart.
- •- 18F*PSMA*PET*CT positive metastases in bones and/or lymph nodes
- •(miN1/miM1ab): Minimally 2 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 refuse
- •these treatments).
- •- No prior hormonal therapy (including any androgen directed treatment such as
- •finasteride,
- •dutasteride, bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane
- •chemotherapy (docetaxel or cabazitaxel);
- •Exception: local prostate cancer treated with local radiotherapy plus adjuvant
- •androgen deprivation therapy (ADT); these
- •patients need to be stopped with ADT at least 12 months.
- •- Testosterone > 1.7 nmol/l.
- •- A detectable lesion on the 18F*PSMA PET/CT with significant PSMA avidity,
- •defined by a SUVmax > 15 (partial volume corrected).
- •- ECOG 0*1
- •- Patients must have a life expectancy >12 months.
- •- Laboratory values:
- •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.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in
- •this study in case of:
- •- A known subtype other than prostate adenocarcinoma.
- •- Previous PSMA based radioligand treatment.
- •- Visceral or brain metastases.
- •- Any medical condition present 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
- •- Sjögrens syndrome
- •- A second active malignancy other than prostate cancer.
研究者
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