NL-OMON50037招募中2 期
Radio guided lymph node dissection in oligo metastatic prostate cancer patients - DETECT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
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 cancer of the prostate, based on prostate biopsy-core
- •At least one 68Ga/18F-PSMA-PET/CT positive metastasis in lymph nodes, located
- •Patient is scheduled and fit for robot assisted surgery (PLND or radical
- •prostatectomy +PLND).
- •Patient is suitable for PLND (and radical prostatectomy) conform institutional
- •guidelines and is not yet treated pre-operatively. (Prior prostate cancer
- •treatment is defined as prostate and/or pelvic radiotherapy, hormonal
- •treatments such as androgen deprivation therapy, prostate brachytherapy,
- •prostate cryotherapy, high intensity focused ultrasound (HIFU) and/or prostate
- •electroporation.)
- •Age>=50 years.
- •Ability to give voluntary written informed consent to participate in this
排除标准
- •No detectable lesion on the 68Ga/18F-PSMA-PET/CT with an uptake level above
- •liver uptake level.
- •Patients who are not scheduled for PLND.
- •Prior pelvic surgery assosiated with pelvic lymphadenopathy.
- •Unequivocal evidence of metastases outside the pelvis.
- •Presence of any medical condition that in the opinion of the
- •investigator/treating physician will affect patients* clinical status by
- •participating in this trial.
- •Prior prostate cancer treatment in the form of surgery, radio-, hormonal- or
- •chemotherapy.
- •Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal
- •clips, metallic bodies in the eye, implanted electric and electronic devices
- •not eligible for MRI (pacemakers, insulin pumps, cochlear implants,
- •neurostimulators).
- •Inability to lie still for at least 60 minutes or comply with imaging.
- •Contraindication for iron infusion or hypersensitivity/allergy to the active
- •substance or any of the excipients.
- •The patient is already enrolled in one or more concurrent studies, which would
- •confound the results of this study, according to the investigators.
研究者
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