Prostate Cancer
Conditions
Interventions
Two cycles of 177Lu-PSMA RLT in patients, prior to RARP + ePLND
Sponsors
To be determined
Eligibility
Inclusion criteria
Inclusion criteria: 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 - Leucocytes = 3.0 x 109/L - Thrombocytes = 100 x 109/l - Provided informed consent
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histopathological response to 177Lu-PSMA RLT in the resected prostate specimen and in the resected lymph nodes | — |
Secondary
| Measure | Time frame |
|---|---|
| - To study the tolerability of study medication and assessment of quality of life (QoL) by patient reported outcome measures and specific QoL questionnaires using the EORTC Quality of Life Questionnaire for cancer patients (EORTC-QLQC30 and EORTC-QLQ-BM22) [19] at baseline and four weeks after each cycle of 177Lu-PSMA RLT. - To assess the prostate-specific antigen (PSA) free survival at 12 months after two cycles of 177Lu-PSMA RLT and concurrent RARP and ePLND. | — |
Contacts
Public ContactDennie Meijer
Amsterdam UMC, VU University Medical Center
Outcome results
None listed