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Clinical Trial · NCT04343885
In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy
Overview
This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).
Sponsor
Peter MacCallum Cancer Centre
Phase
Phase 2
Contacts
Michael Hofman, MBBS(Hons),FRACP,FAANMS,FICIS (PRINCIPAL_INVESTIGATOR)
Arun Azad, MBBS PhD FRACP (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT04343885Drug / Compound
PSMA-617
Isotope(s):
LUTETIUM-177
Radioisotope: Lu-177
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 6.7 Days
Decay Mode: BETA, GAMMA
Energy: Eβeta max 497 keV, Gamma 113-208 keV
Range: In Tissue: 0.25-2mm
Decay Daughters: Hf177
Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
Target(s):
- PSMA
Ligand Class: Small Molecules
Chelator: DOTA
Eligibility
Inclusion
- Prostate cancer diagnosed within 12 weeks of commencement of screening
Exclusion
Exclusion criteria not yet provided.
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