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 - SHEPHERD trial

Not provided0 sites10 target enrollmentJune 24, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: prostate cancer, eligible for radical prostatectomy and extended pelvic lymph node dissection, with 1-3 pelvic nodal metastases on preoperative PSMA PET
Sponsor: Not provided
Enrollment: 10
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

June 24, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Not provided

•\-Men over 18 years of age
•\-ECOG performance score (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 with a maximum of 6 weeks before study entry
•\-An mpMRI of the abdomen with a maximum of 12 weeks before study entry
•\-Deemed clinically fit for 177Lu\-PSMA RLT
•\-eGFR \= 30 mL/min/1\.73 m2
•\-Hemoglobin (Hb) \= 5\.6 mmol/L

•\-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)