177Lu-PSMA Radioligand therapy in patients with lymph node metastatic hormone-sensitive prostate cancer undergoing robot-assisted laparoscopic radical prostatectomy and extended pelvic lymph node dissection

To be determined0 sites10 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

To be determined

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•\-Men over 18 years of age
•\-ECOG PS 0\-1
•\-Histologically proven adenocarcinoma of the prostate cancer of any grade and/or stage
•\-Any prostate\-specific antigen (PSA)\-level
•\-Planned to undergo radical prostatectomy (RARP) and extended pelvic lymph node dissection (ePLND)
•\-A pre\-operative \[68Ga] or \[18F] PSMA PET/CT positive for lymphogenic metastatic disease (1\-3 metastases; miN1\) in the surgical template
•\-Deemed clinically fit for 177Lu\-PSMA RLT
•\-eGFR \= 30 mL/min/1\.73 m2
•\-Hemoglobin (Hb) \= 5\.6 mmol/L

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•\-Previous treatment with any of the following within 6 months of inclusion:
•Strontium\-89, Samarium\-153, Rhenium\-186, Rhenium\-188, Radium\-223, hemi\-body irradiation
•\-Previous PSMA\-targeted radioligand therapy
•\-Any systemic anti\-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies]) within 28 days prior to day of inclusion
•\-Known hypersensitivity to the components of the study therapy or its analogs
•\-Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
•\-Patients with signs of M1a\-b\-c disease on pre\-operative PSMA PET/CT
•\-Prior systemic hormonal therapy (ADT)