Pilot study to evaluate dosimetry and toxicity of lutetium-177-PSMA-617 radioligand therapy in low volume, hormone sensitive metastatic prostate cancer - Pilot study: Lutetium-177-PSMA-617 in low volume metastatic prostate cancer

Radboud Universitair Medisch Centrum0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•- Histological proven adenocarcinoma of the prostate ;- Prior local therapy for prostate cancer;- Biochemical recurrence or clinical progression after local therapy (PSA > 0.2 µg/l), PSA-DT < 6 months);- 68Ga-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): *1, maximally 10 metastases (minimal lesion size 1 cm to enable adequate dosimetry studies) ;- 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 or chemotherapy; testosteron > 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 3 months;- No visceral metastases ;- Laboratory values: ;* White blood cells * 3.5 x 10^9/l ;* Platelet count * 150 x 10^9/l ;* Hemoglobin * 6 mmol/l ;* ASAT, ALAT * 3 x ULN ;* MDRD-GFR * 60 ml/min ;-Signed informed consent

•- A known subtype other than prostate adenocarcinoma;- 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 and nanoMRI;- Contra-indication for MRI imaging (claustrophobia, implanted electric and electronic devices (heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators), intracranial metal clips, metallic bodies in the eye)

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