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RECRUITINGPHASE1/PHASE2

EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T

EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T: Phase I/II Study

NCT05521412•Peter MacCallum Cancer Centre, Australia

View on ClinicalTrials.gov

Summary

This clinical trial will evaluate the safety and efficacy of \[161Tb\]Tb -PSMA-I\&T in men with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description

This prospective, single-centre, single-arm phase I/II trial will assess the safety, efficacy and anti-tumour activity of \[161Tb\]Tb-PSMA-I\&T in patients with mCRPC. This study aims to assess and establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of \[161Tb\]Tb-PSMA-I\&T in patients with mCRPC. 42 men with mCRPC who have progressed with at least one line of taxane chemotherapy and at least one second-generation androgen receptor (AR)-targeted agent will be enrolled in this trial in two stages: dose escalation and a dose expansion phase over a period of 24 months.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Patient has provided written informed consent.
•2. Male patients must be 18 years of age or older at the time of written informed consent.
•3. Histologically or cytologically confirmed adenocarcinoma of the prostate, OR unequivocal diagnosis of metastatic prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) with an elevated serum prostate specific antigen (PSA).
•4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
•5. Patients must have had prior treatment with at least one line of taxane chemotherapy, unless medically unsuitable.
•6. Patients must have had prior treatment with at least one second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, apalutamide or darolutamide).
•7. Patients must have progressive disease defined according to The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) as any one of the following:
•1. PSA progression - minimum of 2 rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement
•2. Soft tissue progression as per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) criteria
•3. Bone progression: ≥ 2 new lesions on bone scan
+14 more criteria

Exclusion Criteria

•1. Prior treatment with another radioisotope (i.e. PSMA radioligands, radium-223, strontium-89, samarium-153).
•2. Site(s) of discordant disease on PET imaging (Fluorodeoxyglucose \[FDG\]-positive and minimal PSMA-uptake).
•3. Other malignancies (in addition to the prostate cancer being treated on this study) within the previous 2-years prior to registration other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.
•4. Symptomatic brain metastases or leptomeningeal metastases.
•5. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for more than 4 weeks.
•6. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.

Locations (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Key Dates

Start Date

September 29, 2022

Primary Completion Date

August 3, 2025

Completion Date

December 1, 2026

Last Updated

April 6, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate CancerMetastatic Castration-resistant Prostate Cancer

Interventions

[ 161 Tb]Tb PSMA I&T

DRUG

Contacts

James Butaeu, MD

CONTACT

(03) 855 96650 James.Buteau@petermac.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T

Inclusion Criteria

Exclusion Criteria

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