Metastatic Castration Resistant Prostate Cancer
Conditions
Interventions
This is a designed to investigate and confirm the benefits and risks associated with 177Lu-TLX591 administered together with SOC compared to SOC alone, in participants with PSMA-positive metastatic ca
Sponsors
Yoshino Shuta
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male, at least 18 years old, with documented adenocarcinoma of the prostate defined by histological / pathological confirmation - Confirmed mCRPC (defined as >=1 metastatic lesions present on baseline CT, MRI, or bone scintigraphy) - Disease that is PSMA positive, as demonstrated by a 68Ga-PSMA-11 PET/CT scan or PET/MRI - ECOG Performance Status 0, 1, or 2 with an estimated life expectancy of >= 6 months from Day 1 - Must have received a minimum of 12 weeks of prior therapy on their first ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide), received in either the mCSPC, nmCRPC, or mCRPC treatment settings. Participants may have received docetaxel in the mCSPC setting (up to 6 cycles of docetaxel) provided the last dose of docetaxel was >= 6 months prior to screening and >= 4 cycles of docetaxel were administered. - Must have recovered to <= Grade 1 from all clinically significant toxicities related to prior therapies
Exclusion criteria
Exclusion criteria: - Have received prior treatment with monoclonal antibody HuJ591 or any other PSMA-targeted radioligand therapy - Have received chemotherapy in the mCRPC setting (note: prior docetaxel uses in the mCSPC setting is permitted if the last dose of therapy was >= 6 months prior to screening and >= 4 cycles of docetaxel were administered). - Has PC associated with pathological findings consistent with small cells or any histology other than adenocarcinoma of the prostate. If there are minor (=1cm - History of stroke or seizure within the last 6 months - Has received treatment with any PARP inhibitors (i.e., olaparib) or with any platinum based anti-neoplastic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main evaluation items are as follows: Part1 the clinical safety and tolerability of 177Lu-TLX591 the pharmacokinetics (PK), biodistribution (BD), and radiation dosimetry Part2 Radiographic Progression-free Survival Overall Survival Objective Response Rate (ORR) Time to a first symptomatic skeletal event (SSE) | — |
Countries
Australia, Belgium, Brazil, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Singapore, South Korea, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactJiro Takayama
IQVIA Services Japan G.K.
Outcome results
None listed