Abstract
ProstACT GLOBAL: A phase 3 study of best standard of care with and without 177Lu-DOTA-rosopatamab (TLX591) for patients with PSMA expressing metastatic castration-resistant prostate cancer progressing despite prior treatment with a novel androgen axis drug.
Author
person
Oliver Sartor
Mayo Clinic, Rochester, MN
info_outline
Oliver Sartor, Scott T. Tagawa, Nat Lenzo, David Cade, Neeraj Agarwal
Full text
Authors
person
Oliver Sartor
Mayo Clinic, Rochester, MN
info_outline
Oliver Sartor, Scott T. Tagawa, Nat Lenzo, David Cade, Neeraj Agarwal
Organizations
Mayo Clinic, Rochester, MN, Weill Cornell Medical College of Cornell University, New York, NY, Genesiscare, East Fremantle, Australia, Telix Pharmaceuticals, Fishers, Huntsman Cancer Institute, Salt Lake City, UT
Abstract Disclosures
Research Funding
No funding sources reported
Background:
The treatment of advanced prostate cancer (PC) is challenging, with no curative therapy to date and undesirable side effects that may impact patient quality of life. Monoclonal antibodies enable high specificity with low rates of off-target organ exposure, prolonged retention in PSMA+ tumors, and a predictable safety profile. There is a strong rationale for further investigation of the
177
Lu-labeled, chelator-conjugated antibody,
177
Lu-DOTA-rosopatamab (hereafter, TLX591), with prior studies demonstrating a favorable safety profile and efficacy, particularly with a fractionated (dose-dense) regimen Phase 1 ProstACT SELECT preliminary results demonstrate consistent uptake between TLX591 and
68
Ga-PSMA-11 imaging and reinforces advantages of this first-in-class radio-antibody drug conjugate investigational therapy.
Methods:
In this multinational, multicenter, prospective, randomized, open label phase 3 study, patients (N=400) with PSMA-expressing metastatic castration-resistant PC (mCRPC) that have progressed despite prior treatment with an androgen-receptor pathway inhibitor (ARPI) will be enrolled in a 2:1 ratio to receive best protocol-defined standard of care (SoC) with or without 2 intravenous injections of 2.8 GBq of TLX591, given 14 days apart. SoC may be alternative ARPI or docetaxel. Eligible patients must have received 1 prior ARPI in the mCSPC, nmCRPC, or 1L mCRPC setting. Patients must have 150x10
9
/L platelets, and have PSMA-positive disease on
68
Ga-PSMA-11 PET/CT imaging. The primary endpoint is radiographic progression-free survival. Secondary endpoints include 5-year overall survival, tumor objective response rate, time to symptomatic skeletal event, health-related quality of life, and treatment-related adverse events count. An alpha control and 95% confidence intervals will be used; patients will be substratified between TLX591 + 2
nd
ARPI or TLX591 + docetaxel. This study is currently enrolling. This study is funded by Telix Pharmaceuticals. Clinical trial information: NCT04876651.
Clinical status
Clinical
2 organizations
5 drugs
1 target
Drug
TLX591Drug
68Ga-PSMA-11Target
PSMADrug
ARPIDrug
docetaxelOrganization
GenesisCare, Fort Myers, FLOrganization
Telix Pharmaceuticals (Innovations)