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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04876651
Registration number
NCT04876651
Ethics application status
Date submitted
3/05/2021
Date registered
6/05/2021
Titles & IDs
Public title
The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only
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Scientific title
A Multinational, Multicenter, Prospective, Randomized, Controlled, Open Label Phase 3 Study With Best Standard of Care With and Without 177Lu-DOTA-rosopatamab for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment With a Novel Androgen Axis Drug
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Secondary ID [1]
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177Lu-TLX591-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - 177Lu-DOTA-rosopatamb
Treatment: Drugs - Standard of Care
Experimental: Group A - Two single intravenous (IV) injections of 76 mCi each (equivalent to a 45 mCi/m2 dose in a standard 1.7m2 individual) of 177Lu-DOTA- rosopatamab, given 14 days apart, plus best Standard of Care
Active comparator: Group B - Participants will receive the Standard of Care
Experimental: Biodistribution and Dosimetry Sub-Study - Two single intravenous (IV) injections of 76 mCi each (equivalent to a 45 mCi/m2 dose in a standard 1.7m2 individual) of 177Lu-DOTA- rosopatamab, given 14 days apart, plus best Standard of Care
Other interventions: 177Lu-DOTA-rosopatamb
Two single intravenous (IV) injections of 76 mCi each (equivalent to a 45 mCi/m2 dose in a standard 1.7m2 individual) of 177Lu-DOTA- rosopatamab, given 14 days apart, plus best SoC
Treatment: Drugs: Standard of Care
enzalutamide or abiraterone \[+ prednisone/prednisolone)\] or docetaxel
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Comparison of radiographic progression-free survival (rPFS)
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Assessment method [1]
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Radiographic progression-free survival (rPFS) defined as the time from randomization to disease progression confirmed by central independent radiology review according to RECIST 1.1 (for soft tissue disease) and/or PCWG3 criteria (for bone disease), or death (whichever occurs first).
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Timepoint [1]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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Overall survival (OS), determined from randomization, until death from any cause
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Timepoint [1]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [2]
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Tumour objective response rate (ORR)
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Assessment method [2]
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Tumor response in terms of objective response rate (ORR) (malignant soft tissue response and overall radiological response \[malignant soft tissue response by RECIST 1.1 and overall radiological response by RECIST 1.1 and PCWG3\]).
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Timepoint [2]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [3]
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Time to a first Symptomatic Skeletal Event (SSE)
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Assessment method [3]
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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
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Timepoint [3]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [4]
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Progression-free survival
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Assessment method [4]
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PFS defined as the time from randomization to disease progression confirmed by radiology, clinical or PSA progression, or death (whichever occurs first).
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Timepoint [4]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [5]
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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Assessment method [5]
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Assessment of AEs graded by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, vital signs (systolic and diastolic blood pressures, respiratory rate, pulse rate, and body temperature), ECGs, and evaluation of laboratory parameters (biochemistry, hematology, coagulation, and urinalysis).
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Timepoint [5]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [6]
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Adverse events of special interest (AESI)
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Assessment method [6]
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Assessment of any Grade 4 hematological abnormalities and bleeding events and Symptomatic skeletal events (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.
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Timepoint [6]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [7]
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Health-related quality of life by ECOG
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Assessment method [7]
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Quality of Life is to be evaluated using the Eastern Cooperative Oncology Group (ECOG) Performance Scale- From 0 (fully active) to 5 (dead).
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Timepoint [7]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [8]
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Health-related quality of life by FACT-P
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Assessment method [8]
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The Functional Assessment of Cancer Therapy-Prostate (FACT-P) evaluates the physical well-being, social/family well-being, emotional well-being and functional well-being), the results range from "not at all" to "Very much"
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Timepoint [8]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [9]
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Health-related quality of life by BPI-SF
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Assessment method [9]
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The Brief Pain Inventory - Short Form (BPI-SF) where the results vary from 1-4 (mild pain), 5-6 (Moderate pain) and 7-10 (severe pain)
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Timepoint [9]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [10]
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Health-related quality of life by EQ-5D-5L
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Assessment method [10]
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The EQ-5D-5L where the results vary from 1 (no problems) to 5 (extreme problems/unable to do)
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Timepoint [10]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [11]
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Health-related quality of life by EORTC/QQ-C30
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Assessment method [11]
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The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) questionnaire - result is calculated from the mean of 13 of the 15 QLQ-C30 scales (Physical Functioning+ Role Functioning+ Social Functioning+ Emotional Functioning+ Cognitive Functioning+ Fatigue+ Pain+ Nausea_Vomiting+ Dyspnoea+ Sleeping Disturbances+ Appetite Loss+ Constipation+ Diarrhoea) ranging from "not at all" to "Very much"
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Timepoint [11]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [12]
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Assessment of changes in prostate specific antigen (PSA)
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Assessment method [12]
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Percentage change from baseline in PSA level, PSA response, and PSA response duration
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Timepoint [12]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [13]
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Time to radiographic soft tissue progression (TTSTP)
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Assessment method [13]
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Time to radiographic soft tissue progression (TTSTP) defined as time from randomization to radiographic soft tissue progression according to RECIST 1.1 (for soft tissue disease).
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Timepoint [13]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [14]
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Biochemical response as indicated by PSA levels, lactate dehydrogenase (LDH) and alkaline phosphatase (ALP) levels
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Assessment method [14]
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Percentage change from baseline in PSA level, PSA response, and PSA response duration and percentage change from baseline in blood LDH/ALP levels.
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Timepoint [14]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [15]
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Development of anti-drug antibodies (ADA) to 177Lu-DOTA-TLX591
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Assessment method [15]
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A blood test to check if antibodies are formed against the study drug, and how much of the antibodies is formed and if it is enough to neutralize the study drug. ADA can reduce or neutralise the drug's effectiveness as the body tries to neutralize the drug.
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Timepoint [15]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [16]
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Titer of anti-drug antibodies (ADA) to 177Lu-DOTA-TLX591
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Assessment method [16]
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The concentration (ug/mL) of anti-drug antibodies (ADA) to 177Lu-DOTA-TLX591
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Timepoint [16]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [17]
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Duration of positiveness in the development of anti-drug antibodies (ADA) to 177Lu-DOTA-TLX591
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Assessment method [17]
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In case of DA positiveness, this will analise how long the ADA positiveness is measured in the study samples.
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Timepoint [17]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [18]
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Neutralizing anti-drug antibodies (NAb) to 177Lu-DOTA-TLX591
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Assessment method [18]
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How many study samples have been positive (rate) for neutralizing anti-drug antibodies (NAb) to 177Lu-DOTA-TLX591. NAb can neutralize the biological drugs and decrease the drug's efficacy and increase its clearance, resulting in patient secondary unresponsiveness.
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Timepoint [18]
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Day 1 to 5 years after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [19]
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To determine whole body biodistribution (BD) of administered activity 177Lu-DOTATLX591(m17)
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Assessment method [19]
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Evaluate whole body and organs imagining positivity for administered 177Lu-DOTATLX591 (m17)
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Timepoint [19]
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Day 1 to day 23 after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [20]
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To determine organ radiation dosimetry of tracer levels of administered activity 177Lu-DOTATLX591(m17)
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Assessment method [20]
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Evaluate organs absorbed radiation doses of administered 177Lu-DOTATLX591 in PSMA expressing tumours as determined by suitable tumour-to-heathy tissue ratios and residence times.
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Timepoint [20]
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Day 1 to day 23 after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [21]
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To determine pharmacokinetics (PK) of administered activity 177Lu-DOTATLX591
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Assessment method [21]
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Measure whole blood radioactive concentration at each timepoint to determine the radiation PK curve.
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Timepoint [21]
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Day 1 to day 23 after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [22]
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Demonstrate comparability of whole body biodistribution dosimetry of the 177Lu-DOTA-TLX591
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Assessment method [22]
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Qualitative comparison measured in SUV (Standardized Uptake Value) of whole-body biodistribution between 177Lu-DOTA-TLX591 from ProstACT-SELECT participants (NCT04786847) and this study's participants
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Timepoint [22]
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Day 1 to day 23 after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [23]
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Demonstrate comparability of organ uptake dosimetry of the 177Lu-DOTA-TLX591
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Assessment method [23]
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Qualitative comparison measured in SUV (Standardized Uptake Value) of organ uptake between 177Lu-DOTA-TLX591 from ProstACT-SELECT participants (NCT04786847) and this study's participants
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Timepoint [23]
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Day 1 to day 23 after two administrations of 177Lu-DOTA-rosopatamab
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Secondary outcome [24]
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Demonstrate organ radiation dosimetry comparability of the 177Lu-DOTA-TLX591
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Assessment method [24]
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Qualitative comparison of organ dosimetry from ProstACT-SELECT participants (NCT04786847) and 177Lu-DOTA-TLX591 (m17 allotype)
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Timepoint [24]
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Day 1 to day 23 after two administrations of 177Lu-DOTA-rosopatamab
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Eligibility
Key inclusion criteria
1. Be a male, at least 18 years old, with metastatic adenocarcinoma of the prostate defined by histological / pathological confirmation of PC.
2. Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of =6 months.
3. Have metastatic disease (=1 metastatic lesions present on baseline CT, MRI, or bone scan imaging).
4. Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone [LHRH]) and must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
5. In the mCRPC setting, must have received a minimum of 12 weeks of prior therapy with a NAAD, either enzalutamide or abiraterone plus prednisone.
6. Should have received one line of prior taxane therapy or have refused or be ineligible for taxanes
7. Have a disease that is progressing at study entry, despite a castrate testosterone level (<50 ng/dL or <1.7 nmol/L), by the demonstration of at least one of the following:
1. Rising PSA values done in sequence at least 1 week apart and with a minimal starting value of 2.0 ng/mL.
2. Progressive disease or new lesion(s) in the viscera or lymph nodes as per RECIST1.1 or in bone as per Prostate Cancer Working Group 3 [PCWG3; Scher et al., 2016]). Any ambiguous results are to be confirmed by other imaging modality (e.g., CT or MRI scan).
8. Have disease that is PSMA positive, as demonstrated by a 68Ga-PSMA11 PET/CT scan and confirmed as eligible by the Sponsor's central reader (patient must have at least one site of metastatic disease with SUVmax =1.5 times the SUV of normal liver). If the disease meets the criteria for PSMA positivity, but there is one or more soft tissue lesion of = 2 cm that is not PSMA positive, then the patient is to be excluded on the grounds that there is substantial disease which might not respond to the therapy.
9. Must have recovered to = Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, NAAD, chemotherapy, etc.).
10. Can be receiving a bisphosphonate or denosumab regimen provided that the patient has been receiving and tolerating this treatment for =30 days prior to randomization.
11. Have adequate organ function at Screening:
a. Bone marrow: i. Platelets =150×109/L. ii. Absolute neutrophil count >1.5×109/L. iii. Hemoglobin =10g/dL (no red blood cell transfusion in the previous 4 weeks).
b. Liver function: i. Total bilirubin < 1.5×the upper limit of normal (ULN). For patients with known Gilbert's Syndrome <3×ULN is permitted. ii. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <3×ULN OR <5×ULN for patients with liver metastases. c. Renal function: i. Serum/plasma creatinine <1.5×ULN or creatinine clearance =50 mL/min determined using the Cockcroft & Gault formula.
12. Have the capacity to understand the study and be able and willing to comply with all protocol requirements.
13. Patients must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution in order to protect their contacts and the general public, especially if a female partner of the patient is or could be pregnant.
14. Must agree to practice adequate precautions to prevent pregnancy in a partner and to avoid potential problems associated with radiation exposure to the unborn child (Refer to Clinical Trials Facilitation Group, 2020: Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, CTFG, 2020).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Are unable to understand or are unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the Investigator.
2. Have PC associated with pathological findings consistent with small cell or any histology other than adenocarcinoma of the prostate. If there are minor elements of neuroendocrine histology, this is acceptable.
3. Uncontrolled pain.
4. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease-free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, and superficial bladder cancer.
5. Are at increased risk of hemorrhage or bleeding, or with a recent history of a thrombolytic event (e.g., deep vein thrombosis [DVT]/ pulmonary embolism [PE]) and have been administered long-term anti-coagulant or anti-platelet agents.
6. Have received prior treatment with monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy.
7. Have known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients.
8. Have received prior systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, or biological therapy) and/or radiation therapy within 4 weeks of randomization OR if any significant AEs have not resolved to National Cancer Institute (NCI) AE Criteria =2; OR are receiving other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
9. Have received prior treatment with radioisotopes, including but not limited to: 89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium, or hemi-body irradiation within 6 months prior to randomization.
10. Have received other investigational therapy within 4 weeks of randomization.
11. Have known brain metastases or hepatic metastases.
12. Have a history of seizure and/or stroke within past 6 months.
13. Have clinical or radiologic findings indicative of impending cord compression or experience symptomatic cord compression.
14. Have a serious active or sub-clinical infection or angina pectoris (New York Heart Association [NYHA] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, which might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment, particularly with enzalutamide.
15. Have received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs.
16. Have a known alteration in breast cancer genes (BRCA) BRCA1, BRCA2, or Ataxia Telangiectasia Mutated Gene (ATM) gene and are eligible to receive Olaparib therapy according to their institution's SoC
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2028
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Actual
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Sample size
Target
392
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
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Monash Health - Clayton
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Recruitment hospital [4]
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Austin Health - Melbourne
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Recruitment hospital [5]
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'GenesisCare Murdoch' - Murdoch
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3083 - Melbourne
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Telix Pharmaceuticals (Innovations) Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This multinational, multicenter, prospective, randomized, controlled, open label Phase 3 study is designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody, 177Lu DOTA rosopatamab administered together with Standard of Care (SoC), as compared to the best SoC alone. The phase 3 will be conducted in patients with metastatic castration-resistant PC (mCRPC) that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug (NAAD).
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Trial website
https://clinicaltrials.gov/study/NCT04876651
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Brenda Cerqueira, M.Sc
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Address
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Country
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Phone
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+61 83180090
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04876651