RecruitingPhase 3

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

United States520 participantsStarted 2024-07-26

Plain-language 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

Who can participate

Age range18 Years

SexMALE

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Exclusion criteria

✕. PSMA PET eligibility: Screening 68Ga-PSMA-11 PET/CT or PET/MRI will be assessed along with CT, MRI, and bone scans utilizing tumor to liver ratio (TLR) for PSMA positivity-based exclusion. TLR is defined as the ratio of tumor lesion SUVmax to liver SUVmean derived from a 3 cm 3D spherical region of interest (ROI).
✕. Prior malignancy that has been adequately treated and has remained disease-free for at least 3 years (maybe confirmed by a scan, etc.).
✕. Adequately treated non-melanoma skin cancer.
✕. Superficial (non-muscle invasive) bladder cancer that is controlled and stable.

What they're measuring

Radiographic Progression-free Survival

Timeframe: 337days

Trial details

NCT IDNCT06520345

SponsorTelix Pharmaceuticals (Innovations) Pty Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Metastatic Castration-resistant Prostate Cancer trials