prostate cancer prostate malignancy
Conditions
Interventions
After screening and baseline imaging with either [68Ga] or [18F] PSMA PET/CT
and mpMRI, patients with lymph node metastatic HSPCa will be planned for two
cycles of neo-adjuvant systemic 177Lu-PSMA R
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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) - >3 lymph node metastases on preoperative PSMA PET - Complete urinary incontinence, not willing to have an indwelling urinary catheter.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is hypothesized that neo-adjuvant systematic treatment with 177Lu-PSMA RLT does not impede the timing of the surgical procedure nor the surgical procedure itself. | — |
Secondary
| Measure | Time frame |
|---|---|
| Furthermore, it is hypothesized that systematic treatment with 177Lu-PSMA RLT and concurrent local radical treatment leads to a histological response in the resected prostate specimen and in the resected lymph nodes. At last, it is hypothesized that 177Lu-PSMA RLT leads to a sustained disease-free survival after 12 months in a substantial subset of patients in newly diagnosed, locally advanced, HSPCa with an acceptable toxicity and with a minimal effect on QoL and well-being. | — |
Countries
Netherlands
Outcome results
None listed