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Radioisotope Therapy

177Lu-TLX591 for Advanced Prostate Cancer

Phase 3

Recruiting

Research Sponsored by Telix Pharmaceuticals (Innovations) Pty Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Have disease that is PSMA-positive, as demonstrated by a 68Ga-PSMA-11 PET/CT or PET/MRI scan and confirmed as eligible by the Sponsor's appointed BICR.

* Progressive disease or new lesion(s) in the viscera or lymph nodes as per RECIST1.1 or in bone as per PCWG3. Any ambiguous results are to be confirmed by other imaging modalities (e.g., CT or MRI scan).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to see how well 177Lu-TLX591 works and how safe it is for patients with advanced prostate cancer that has spread, despite previous treatment with medicines that target the androgen

Who is the study for?

This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread despite treatment. They should have had prior therapy with specific drugs, be in relatively good health (ECOG status 0-2), and have a life expectancy of at least 6 months. Men who've received certain treatments like docetaxel must meet additional time criteria since their last dose.

What is being tested?

The study tests the effectiveness and safety of a new drug, 177Lu-TLX591, combined with standard care versus standard care alone in patients whose prostate cancer has worsened after Androgen Receptor Pathway Inhibitor Treatment. Standard care includes drugs like Docetaxel, Enzalutamide, Abiraterone.

What are the potential side effects?

Potential side effects may include reactions related to radiation exposure from the drug such as nausea or fatigue; blood-related issues due to chemotherapy agents like Docetaxel; hormonal changes from therapies like Enzalutamide and Abiraterone could affect mood or energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is PSMA-positive as shown by a specific scan.

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My cancer has spread or worsened, confirmed by scans.

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I am a man over 18 with confirmed prostate cancer.

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I can care for myself and am expected to live 6 months or more.

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I have cancer that has spread to other parts of my body.

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My PSA levels have increased twice in a row, with the last reading at least 2.0 ng/mL.

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My prostate cancer is getting worse despite hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiographic Progression-free Survival

Secondary study objectives

Objective Response Rate (ORR)

Overall Survival

Time to a first symptomatic skeletal event (SSE)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 177Lu-TLX591 + Enzalutamide or Abiraterone or DocetaxelExperimental Treatment4 Interventions

Lutetium (177Lu) rosopatamab tetraxetan (177Lu-TLX591) 76 mCi (±10%) given approximately 14 days apart, plus SOC. SOC is either: Concurrent enzalutamide (starting dose 160 mg daily) + prednisone / prednisolone (5 mg twice a day) or equivalent. or Concurrent abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (5 mg once daily for the standard formulation), methylprednisolone (4 mg twice daily for the fine particle formulation) or dexamethasone (1 mg once daily) or Sequential Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone (5mg twice a day) or equivalent for up to 10 cycles.

Group II: Control Arm (Enzalutamide or Abiraterone or Docetaxel)Active Control3 Interventions

SOC is either: Enzalutamide (starting dose 160 mg daily) + prednisone / prednisolone (5 mg twice a day) or equivalent. or Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (5 mg once daily for the standard formulation), methylprednisolone (4 mg twice daily for the fine particle formulation) or dexamethasone (1 mg once daily) or Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone (5mg twice a day) or equivalent for up to 10 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Enzalutamide

2014

Completed Phase 4

~3820