RecruitingPhase 3NCT06520345

The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment


Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

430 participants

Start Date

Jul 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a radioactive drug called 177Lu-TLX591 (which targets a protein called PSMA on prostate cancer cells) to standard-of-care treatment helps men with advanced prostate cancer that has spread and is no longer responding to hormone therapy. **You may be eligible if...** - You are male, 18 or older, with confirmed prostate cancer that has spread (metastatic) - Your cancer has become "castration-resistant" (progressing despite testosterone suppression) - You have already received at least 12 weeks of a hormonal treatment (such as enzalutamide, abiraterone, apalutamide, or darolutamide) - Your cancer tests positive for the PSMA protein on a special PET scan - You are in reasonably good health (ECOG 0–2) with a life expectancy of at least 6 months - Your PSA is rising or you have new/worsening lesions **You may NOT be eligible if...** - You have brain metastases larger than 1 cm - You have not had the required PSMA PET/CT scan - Your prior docetaxel treatment was less than 6 months ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-TLX591

Participants randomized to Group A will receive two 76 mCi (±10%) doses of 177Lu-TLX591 14 days apart

DRUGEnzalutamide

Enzalutamide (starting dose 160 mg daily) + prednisone / prednisolone (5 mg twice a day) or equivalent.

DRUGAbiraterone

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)

DRUGDocetaxel

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


Locations(15)

Chao Family Comprehensive Cancer Centre

Orange, California, United States

Biogenix Molecular LLC

Miami, Florida, United States

United Theranostics

Glen Burnie, Maryland, United States

XCancer Omaha

Omaha, Nebraska, United States

Columbia University Herbert Irving Comphrensive Cancer Center

New York, New York, United States

University Hospital

Cleveland, Ohio, United States

OHSU Knight Cancer Center

Portland, Oregon, United States

Intermountain Health

Murray, Utah, United States

Intermountain Health

Salt Lake City, Utah, United States

Westmead Hospital

Sydney, New South Wales, Australia

Nepean Hospital

Sydney, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Australian Prostate Centre

Melbourne, Victoria, Australia

GenesisCare Murdoch

Perth, Western Australia, Australia

Auckland City Hospital

Grafton, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

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NCT06520345


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