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 DISSECTIO

Phase 1

• Conditions: prostate cancer, eligible for radical prostatectomy and extended pelvic lymph node dissection, with 1-3 pelvic nodal metastases on preoperative PSMA PET; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2020-004991-16-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-24
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

-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
-Leucocytes = 3.0 x 109/L
-Thrombocytes = 100 x 109/l
-Provided 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 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified