Trial · NCT05383079

Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men with Metastatic Castration-Resistant Prostate Cancer

NCT05383079, Phase 1, Phase 2, Active not recruiting, Peter MacCallum Cancer Centre, Australia

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men with Metastatic Castration-Resistant Prostate Cancer. Trials, record NCT05383079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05383079

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men with Metastatic Castration-Resistant Prostate Cancer
NCT number: NCT05383079
Status: Active not recruiting
Phases: Phase 1, Phase 2
Enrollment: 36 participants, estimated
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Conditions: Metastatic Castration-resistant Prostate Cancer, MCRPC, Prostate Cancer
Interventions: Lutetium-177 PSMA-I&T, Radium-223
First posted: 2022-05-19
Last updated: 2025-02-07

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Dose Limiting toxicities (DLTs)	Dose escalation phase is expected to be completed 6 months from the time the first patient is recruited.	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.
Primary	Maximum Tolerated dose (MTD)	Dose escalation phase is expected to be completed 6 months from the time the first patient is recruited.	The MTD is defined as the highest dose level at which the incidence of DLT was less than 2/6.
Primary	Recommended Phase 2 Dose (RP2D)	Up to 30 months from the time the first patient is recruited.	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.
Primary	50% Prostate-Specific Antigen Response Rate (PSA-RR)	Through study completion, up until 12 months after the last patient commences treatment	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.
Secondary	Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0	Through study completion, up until 12 months after the last patient commences treatment	Safety of the combination will be measured by AEs and SAEs.
Secondary	Radiographic Progression-Free Survival (rPFS)	Through study completion, up until 12 months after the last patient commences treatment	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.
Secondary	PSA progression free survival (PSA-PFS)	Through study completion, up until 12 months after the last patient commences treatment	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.
Secondary	Overall survival (OS)	Through study completion, up until 12 months after the last patient commences treatment	OS is defined as the time from treatment initiation to the date of death due to any cause.
Secondary	Objective response rate (ORR) by RECIST1.1 in patients with measurable disease	Through study completion, up until 12 months after the last patient commences treatment	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.
Secondary	Progression Free Survival (PFS)	Through study completion, up until 12 months after the last patient commences treatment	Time from randomisation to the date of PSA progression, or radiographic progression (PCWG3 for bone and RECIST 1.1 for soft tissue), or death.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36465905	DERIVED	PubMed
41119954	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05383079

GET https://conductscience.org/api/trials/v1/NCT05383079/registered

API reference For AI assistants