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Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer
This clinical trial will evaluate the safety of Radium-223 in combination with 177Lu-PSMA-I\&T in metastatic castration-resistant prostate cancer: Phase I/II study.
Study details:
This prospective, single-centre, single-arm, open label, phase I/II trial will assess and establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of Radium-223 in combination with 177Lu-PSMA-I\&T in patients with mCRPC. 36 men with mCRPC who have progressed on second-generation AR antagonist will be enrolled in this trial in two stages: dose escalation and a dose expansion phase over a period of 24 months.
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: 2022-09-13
Primary completion: 2026-06-01
Study completion finish: 2026-12-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05383079
Intervention or treatment
DRUG: Lutetium-177 PSMA-I&T
DRUG: Radium-223
Conditions
- • Metastatic Castration-resistant Prostate Cancer
- • mCRPC
- • Prostate Cancer
Find a site
Closest Location:
Peter MacCallum Cancer Centre
Research sites nearby
Select from list below to view details:
Peter MacCallum Cancer 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: Radium-223 and Lutetium-177 PSMA-I&T
| DRUG: Lutetium-177 PSMA-I&T
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Dose Limiting toxicities (DLTs) | A DLT is defined as a toxicity that prevents further administration of the trial treatment at that dose level. Each cohort of 3 patients be assessed for DLTs in the first 6 weeks (cycle 1) of treatment and a dose for the next cohort will be determined. | Dose escalation phase is expected to be completed 6 months from the time the first patient is recruited. |
Maximum Tolerated dose (MTD) | The MTD is defined as the highest dose level at which the incidence of DLT was less than 2/6. | Dose escalation phase is expected to be completed 6 months from the time the first patient is recruited. |
Recommended Phase 2 Dose (RP2D) | After the MTD is established, additional patients will be treated at the MTD. Safety and efficacy data from the study will be used to define the RP2D. | Up to 30 months from the time the first patient is recruited. |
50% Prostate-Specific Antigen Response Rate (PSA-RR) | PSA will be assessed at baseline and every 3 weeks from cycle 1 day 1. PSA response will be defined as a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. | Through study completion, up until 12 months after the last patient commences treatment |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | Safety of the combination will be measured by AEs and SAEs. | Through study completion, up until 12 months after the last patient commences treatment |
Radiographic Progression-Free Survival (rPFS) | rPFS is defined as the time from treatment initiation to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first. The radiographic progression will be assessed by the investigator per RECIST1.1 for soft tissue and PCWG3 for bone lesions. | Through study completion, up until 12 months after the last patient commences treatment |
PSA progression free survival (PSA-PFS) | PSA-PFS is defined as the time from treatment initiation to the date of PSA progression per PCWG3 or death due to any cause, whichever occurs first. The date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2ng/mL or more from the nadir is documented. For patients who have an initial PSA decline during treatment, this must be confirmed by a second value 3 or more weeks later. | Through study completion, up until 12 months after the last patient commences treatment |
Overall survival (OS) | OS is defined as the time from treatment initiation to the date of death due to any cause. | Through study completion, up until 12 months after the last patient commences treatment |
Objective response rate (ORR) by RECIST1.1 in patients with measurable disease | Objective Response (OR) is only applicable for the subset of patients with measurable disease by RECIST1.1. OR is defined as a partial response (PR) or complete response (CR) at any stage from time of commencement of protocol treatment to the time of subsequent systemic anti-cancer treatment. The ORR is calculated as the proportion of patients with a best response of CR or PR. | Through study completion, up until 12 months after the last patient commences treatment |
Progression Free Survival (PFS) | Time from randomisation to the date of PSA progression, or radiographic progression (PCWG3 for bone and RECIST 1.1 for soft tissue), or death. | Through study completion, up until 12 months after the last patient commences treatment |
Describe pain within 12 months of treatment commencement | Pain will be assessed using the Brief Pain Inventory - Short Form (BPI-SF). The primary endpoint for pain is the area under the curve (AUC) of the worst pain in 24h. Pain and QoL will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months and will be scored according to the respective manuals. | Through completion of 12 months after treatment commencement of last patient |
Describe health-related QoL within 12 months of treatment commencement | QoL will be assessed using the Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) questionnaire. The primary endpoint for QoL is the area under the curve (AUC) of the trial outcome index (TOI). QoL will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months and will be scored according to the respective manuals. | Through completion of 12 months after treatment commencement of last patient |
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