ARDT

DRUG3 trials

Sponsors

Novartis Pharmaceuticals

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)Prostatic Neoplasms

Phase 2

A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer

Active, not recruitingNCT05658003

Novartis PharmaceuticalsMetastatic Castration-Resistant Prostate Cancer (mCRPC)

Start: 2023-05-05End: 2027-01-13Updated: 2026-03-23

Phase 3

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

Active, not recruitingNCT04689828

Novartis PharmaceuticalsProstatic Neoplasms

Start: 2021-06-15End: 2026-09-30Updated: 2026-03-23

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Active, not recruitingNCT04720157

Novartis PharmaceuticalsProstatic Neoplasms

Start: 2021-06-09End: 2027-02-11Updated: 2026-03-11

Related Papers

Final overall survival and safety analyses of the phase III PSMAfore trial of [<sup>177</sup>Lu]Lu-PSMA-617 versus change of androgen receptor pathway inhibitor in taxane-naive patients with metastatic castration-resistant prostate cancer.

2025-07-178 citations

Health-related quality of life, pain, and symptomatic skeletal events with [<sup>177</sup>Lu]Lu-PSMA-617 in patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): an open-label, randomised, phase 3 trial.

2025-05-265 citations

Association of baseline and on-treatment ctDNA fraction with clinical outcomes in patients with mCRPC in the PSMAfore study of <sup>177</sup> Lu-PSMA-617.

Journal of Clinical Oncology2025-02-102 citations

Long-term safety outcomes of <sup>177</sup> Lu-PSMA-617 in patients with prostate cancer.

Journal of Clinical Oncology2025-02-101 citations

<sup>177</sup>Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial.

2024-09-15129 citations

Baseline ctDNA analyses and associations with outcomes in taxane-naive patients with mCRPC treated with <sup>177</sup>Lu-PSMA-617 versus change of ARPI in PSMAfore.

Journal of Clinical Oncology2024-06-0111 citations

Health-related quality of life and pain in a phase 3 study of [<sup>177</sup>Lu]Lu-PSMA-617 in taxane-naïve patients with metastatic castration-resistant prostate cancer (PSMAfore).

Journal of Clinical Oncology2024-06-015 citations

P2-04 EFFICACY OF [ <sup>177</sup> Lu]Lu-PSMA-617 VERSUS ARPI CHANGE IN TAXANE-NAIVE PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER BY PRE-RANDOMIZATION ARPI (PSMAFORE)

The Journal of Urology2024-05-01

Nearly double the patients and dramatic changes over 14 years of UK MRT: Internal Dosimetry Users Group survey results from 2007 to 2021

Nuclear Medicine Communications2023-10-304 citations

PSMAddition: A phase 3 trial to compare treatment with <sup>177</sup>Lu-PSMA-617 plus standard of care (SoC) and SoC alone in patients with metastatic hormone-sensitive prostate cancer.

Journal of Clinical Oncology2023-06-0125 citations

The use of Lutetium-177 PSMA radioligand therapy with high dose rate brachytherapy for locally recurrent prostate cancer after previous definitive radiation therapy: a randomized, single-institution, phase I/II study (ROADSTER).

2023-04-207 citations

Tolerability of concurrent external beam radiotherapy and [177Lu]Lu-PSMA-617 for node-positive prostate cancer in treatment naïve patients, phase I study (PROQURE-I trial)

BMC Cancer2023-03-2313 citations

PSMAddition: A phase 3 trial to compare treatment with <sup>177</sup>Lu-PSMA-617 plus standard of care (SOC) versus SOC alone in patients with metastatic hormone-sensitive prostate cancer.

Journal of Clinical Oncology2022-02-1640 citations

PSMAfore: A phase 3 study to compare <sup>177</sup>Lu-PSMA-617 treatment with a change in androgen receptor pathway inhibitor in taxane-naïve patients with metastatic castration-resistant prostate cancer.

Journal of Clinical Oncology2022-02-1621 citations