Oligo-metastatic adenocarcinoma of the prostate.
Conditions
Interventions
Trade Name: Pluvicto 1 000 MBq/mL solution for injection/infusion
Product Name: Pluvicto 1 000 MBq/mL solution for injection/infusion
Pharmaceutical Form: Solution for injection
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Histological proven adenocarcinoma of the prostate with archived tumor material. - Biochemical recurrence or clinical progression (PSA > 1.0 µg/l). - ECOG 0-1. - PSA-doubling time 1.7 nmol/l. Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 6 months. - No visceral metastases. - Laboratory values: • White blood cells > 3.0 x 109/l • Platelet count > 75 x 109/l • Hemoglobin > 6.2 mmol/l • ASAT, ALAT =65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: - A detectable lesion on the 18F-PSMA PET/CT with significant PSMA avidity, defined by a SUVmax > 10 (partial volume corrected). - A known subtype other than prostate adenocarcinoma. - Previous PSMA based radioligand treatment. - Visceral or brain metastases. - Any medical condition present that in the opinion of the investigator will affect patients' clinical status when participating in this trial. - Prior hip replacement surgery potentially influencing performance of PSMA PET/CT. - Sjogren's syndrome. - A second active malignancy other than prostate cancer. - Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess the difference in the fraction of patients with low volume, hormone sensitive metastatic PCa that meet EOT 1 criteria after 177Lu-PSMA RLT compared to those that have a deferred androgen deprivation treatment schedule. EOT 1 is defined by: - Clinical progression determined by the treating physician (e.g. increasing pain from metastases) - A 100% increase in PSA after cycle one blood draw (BASELINE) during study. Exception: PSA increase in the first 12 weeks after the first treatment injection as was defined by the PCWG3 criteria.;Secondary Objective: - To assess ADT free survival in patients receiving 177Lu-PSMA RLT. ADT free survival is defined by the date ADT is started or death related to PCa. - To evaluate the clinical efficacy of multiple doses 177Lu-PSMA radioligand therapy in patients with low volume, hormone sensitive metastatic PCa. - To assess progression free survival, defined as from the time frominclusion to date of evidence of: clinical progression, death from any cause, PSA progression, or radiographic progression, whichever occurs first. - To evaluate the tolerability and toxicity of 177Lu-PSMA RLT defined by NCI Common Terminology Criteria for Adverse Events v5.0. - To evaluate the quality of life before and up to 6 months after 177Lu- PSMA RLT using the following questionnaires: EORTC QLQ-C30, QLQPR25 & xerostomia inventory.;Primary end point(s): To assess the difference in the fraction of patients that have disease progression during the 6 month follow up of this study after 177Lu-PSMA RLT or a deferred androgen deprivation treatment schedule.;Timepoint(s) of evaluation of this end point: End-of-Study (Week 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - ADT-free survival. - PSA response. - Toxicity based on NCI CTCAE v5.0 criteria. - Radiological state of the disease, expressed in the difference in amount and size of suspicious nodes on 18F-PSMA PET/CT and (whole body) MRI between pre- and post-therapy. - Quality of Life assessments.;Timepoint(s) of evaluation of this end point: During study and up to End-of-Study (Week 24). | — |
Countries
Cyprus
Contacts
Public ContactMedical Imaging research office
Radboud University Medical Center
Outcome results
None listed