Study of 177Lu-TLX591 with Standard Care vs. Standard Care Alone in Patients with Advanced Prostate Cancer

Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

Sponsor score: 60

ClinicalTrials ID:NCT06520345

Provider View

This clinical trial is testing a new treatment, 177Lu-TLX591, to see if it can help patients with advanced prostate cancer that has spread and is not responding to hormone therapy. The study compares this new treatment combined with standard care to standard care alone.

Patient Parameters

Program Overview

The study aims to find out if the new treatment, 177Lu-TLX591, is safe and effective for patients with metastatic castration-resistant prostate cancer (mCRPC) who have not responded to previous hormone treatments. The trial will compare how long patients live without their cancer getting worse when they receive 177Lu-TLX591 plus standard care versus standard care alone.

Description

The study is divided into three parts:

  • Part 1: Safety and Dosimetry Lead-in

    • This initial phase involves 30 patients to ensure the treatment is safe and to determine the right dose.

  • Part 2: Randomized Treatment Expansion

    • About 400 patients will be randomly assigned to receive either 177Lu-TLX591 with standard care (Group A) or standard care alone (Group B). Standard care includes either hormone therapy (enzalutamide or abiraterone) or chemotherapy (docetaxel).

  • Part 3: Long-term Follow-up

    • All patients will be monitored for at least 5 years to track their health and any long-term effects of the treatment.

Only patients whose cancer shows a specific marker (PSMA-positive) will be eligible to participate.

Eligibility Criteria

Inclusion Criteria

  • Male, 18 years or older, with confirmed prostate cancer.
  • Good general health with a life expectancy of at least 6 months.
  • Cancer has spread to other parts of the body.
  • Cancer is not responding to hormone therapy and testosterone levels are low.
  • Previously treated with hormone therapy for at least 12 weeks.
  • Cancer is progressing despite low testosterone levels, shown by rising PSA levels or new tumors.
  • Cancer must be PSMA-positive as shown by specific scans.
  • Must have recovered from any significant side effects of previous treatments.
  • Adequate blood cell counts and organ function.
  • Able to understand and follow study requirements.
  • Agree to follow radiation safety guidelines and use contraception to prevent pregnancy in a partner.

Exclusion Criteria

  • Unable to understand or unwilling to sign consent or follow study procedures.
  • Prostate cancer with small cell or other non-adenocarcinoma types.
  • Other cancers that could affect life expectancy or interfere with the study.
  • Recent history of blood clots or bleeding issues.
  • Previous treatment with certain PSMA-targeted therapies.
  • Recent chemotherapy or other cancer treatments.
  • Allergies to the study drug or its components.
  • Recent use of radioisotopes or investigational therapies.
  • Known brain or large liver/bone metastases.
  • Recent seizures, strokes, or spinal cord issues.
  • Serious infections or heart, lung, kidney, liver, or blood disorders.
  • Previous treatment with PARP inhibitors or platinum-based drugs.

Locations

FACILITYZIPCITYSTATE
Chao Family Comprehensive Cancer Centre92868OrangeCalifornia
Biogenix Molecular LLC33165MiamiFlorida
United Theranostics21061Glen BurnieMaryland
XCancer Omaha68130OmahaNebraska
University Hospital44106ClevelandOhio
OHSU Knight Cancer Center97239PortlandOregon
Intermountain Health84107MurrayUtah
Intermountain Health84112Salt Lake CityUtah

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.