Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

In this single-arm study, patients will receive doses of \[161 Tb\]Tb PSMA I\&T on Day 1 of every 6 week Cycle. The dose of \[161 Tb\]Tb PSMA I\&T will vary in dose-escalation. Up to 6 Cycles will be given.

During dose escalation, doses of \[161 Tb\]Tb PSMA I\&T will range between 4.4 GBq to 7.4 GBq. The recommended phase 2 dose of \[161 Tb\]Tb PSMA I\&T will be used during dose expansion. \[161Tb\]Tb-PSMA-I\&T dose will be reduced by 0.4 GBq for each subsequent cycles (2 to 6).

[ 161 Tb]Tb PSMA I&T

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

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.

30-36 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

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

The MTD is defined as the highest dose level at which the incidence of DLT was less than 1/3 or 2/6.

Safety of the combination will be measured by AEs and SAEs.

A DLT is defined as a toxicity that prevents further administration of the trial treatment at that dose level. Each cohort of 3 patients will be assessed for DLTs after 6 weeks from administration of cycle 1.

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.

Absorbed radiation dose will be determined using the SPECT/CT imaging after administration of the first dose of \[161Tb\]Tb-PSMA-I\&T

PSA will be assessed at baseline and every 3 weeks from Cycle 1 Day 1 during treatment, and every 6 weeks during follow-up. PSA response will be defined as a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result.

rPFS is defined as the time from registration to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first. Radiographic progression will be assessed by the Investigator per RECIST 1.1 for soft tissue and PCWG3 for bone lesions

PSA progression is defined as a rise in PSA by more than 25% AND more than 2ng/mL above the nadir (lowest PSA point). This needs to be confirmed by a repeat PSA performed at least 3 weeks later. Early rises in PSA prior to 12 weeks will be disregarded in determining PSA progression.

PFS is defined as the time to PSA progression, radiographic progression, or death due to any cause

OS is defined as the time from treatment initiation to the date of death due to any cause.

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.

Pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF).

HR-QoL will be assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. The endpoint is the trial outcome index (TOI) score from FACT-P

Spots Global Cancer Trial Database for [ 161 tb]tb psma i&t