EUCTR2020-000076-37-CY进行中（未招募）1 期
utetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer. - Bullseye-2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
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
- 性别
- Male
入选标准
- •- Histological proven adenocarcinoma of the prostate with archived
- •tumor material.
- •- Biochemical recurrence or clinical progression (PSA > 1.0 µg/l).
- •- ECOG 0-1.
- •- PSA-doubling time < 6 months.
- •- 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes
- •(N1/M1ab): =1, maximally 5 metastases .
- •- Local treatment for oligometastases with radiotherapy or surgery
- •appears to be no option anymore (due to prior treatment or the location
- •of the metastatic lesions).
- •- No prior hormonal therapy (including any androgen directed treatment
- •such as Bicalutamide, Apalutamide, Abiraterone or Enzalutamide) or
- •taxane based chemotherapy (docetaxel or cabazitaxel); testosterone >
- •1.7 nmol/l.
- •Exception: local prostate cancer treated with local radiotherapy plus
- •adjuvant ADT; these patients need to be stopped with ADT at least 6
- •- No visceral metastases.
- •- Laboratory values:
- •White blood cells > 3.0 x 109/l
- •Platelet count > 75 x 109/l
- •Hemoglobin > 6.2 mmol/l
- •ASAT, ALAT < 3 x ULN
- •MDRD-GFR = 50 ml/min
- •- Signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 43
排除标准
- •- A detectable lesion on the 18F-PSMA PET/CT with significant PSMA
- •avidity, defined by a SUVmax > 10 (partial volume corrected).
- •- 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 affect patients' clinical status when participating in this trial.
- •- Prior hip replacement surgery potentially influencing performance of
- •PSMA PET/CT.
- •- Sjogren's syndrome.
- •- A second active malignancy other than prostate cancer.
- •- Patients who are sexually active and not willing/able to use medically
- •acceptable forms of barrier contraception.
研究者
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