A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment
Telix Pharmaceuticals (Innovations) Pty Limited
Summary
The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment
Description
The primary objective of the study is to compare radiographic progression-free survival (rPFS) in participants who receive 177Lu-TLX591 with SOC to rPFS in participants who receive SOC only. This study consists of three Parts: * Part 1: Safety and Dosimetry Lead-in, * Part 2: Randomized Treatment Expansion, and * Part 3: Long-term Follow-up The study will commence with a 30-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment expansion in approximately 490 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either 177Lu-TLX59…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Be a male, at least 18 years old, with documented adenocarcinoma of the prostate defined by histological / pathological confirmation. * Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥6 months from Day 1. * Have metastatic disease (defined as ≥1 metastatic lesion present on baseline CT, MRI or bone scintigraphy). * Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone \[LHRH\] analogues) and must have a castrate level of serum/plasma testost…
Interventions
- Drug177Lu-TLX591
Participants randomized to Group A will receive two 76 mCi (±10%) doses of 177Lu-TLX591 14 days apart
- DrugEnzalutamide
Enzalutamide (starting dose 160 mg daily)
- DrugAbiraterone
Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (up to 10 mg per day for the standard formulation)
- DrugDocetaxel
Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone 5mg twice a day (or equivalent) for up to 10 cycles
Locations (31)
- Chao Family Comprehensive Cancer CentreOrange, California
- Biogenix Molecular LLCMiami, Florida
- United TheranosticsGlen Burnie, Maryland
- XCancer OmahaOmaha, Nebraska
- Columbia University Herbert Irving Comphrensive Cancer CenterNew York, New York
- University HospitalCleveland, Ohio