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The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT GLOBAL)
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.
Study details:
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 400 patients (Part 2).
Patients in Part 2 will be randomized in a 2:1 ratio to receive either 177Lu-TLX591 + Standard of Care SoC (Group A), or SoC alone (Arm B). SoC in this trial is either: ARPI (enzalutamide or abiraterone) or docetaxel. All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3).
Only patients that meet PSMA-positivity criteria per Blinded Independent Central Review (BICR) will be eligible for this study.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2024-07-26
Primary completion: 2027-12-01
Study completion finish: 2030-12-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06520345
Intervention or treatment
DRUG: 177Lu-TLX591
DRUG: Enzalutamide
DRUG: Abiraterone
DRUG: Docetaxel
Conditions
- • Metastatic Castration-resistant Prostate Cancer
Find a site
Closest Location:
Nepean Hospital
Research sites nearby
Select from list below to view details:
Nepean Hospital
Sydney, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Australian Prostate Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: 177Lu-TLX591 + Enzalutamide or Abiraterone or Docetaxel
| DRUG: 177Lu-TLX591
|
ACTIVE_COMPARATOR: Control Arm (Enzalutamide or Abiraterone or Docetaxel)
| DRUG: Enzalutamide
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Radiographic Progression-free Survival | time from randomization to disease progression confirmed by central independent radiology review according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (which incorporates Response Evaluation Criteria in Solid Tumors, RECIST 1.1, for soft tissue lesions), or death (whichever occurs first) | 337days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall Survival | Defined as the time from randomization, until death from any cause. | 5 years |
Objective Response Rate (ORR) | Tumor response in terms of PCWG3 criteria (which incorporates RECIST 1.1 for soft tissue lesions). | 337days |
Time to a first symptomatic skeletal event (SSE) | Time to a first SSE, defined as the use of external beam radiation to relieve bone pain, or occurrence of a new symptomatic pathological fracture (vertebral or non-vertebral), or occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention. | 337days |
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