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Clinical & Regulatory Updates Topic Center

News
03/11/2026
Stephanie Holland
Based on results from the OSPREY and CONDOR trials, the FDA has approved piflufolastat F 18 injection for the detection of PSMA-positive lesions in patients with prostate cancer.
Based on results from the OSPREY and CONDOR trials, the FDA has approved piflufolastat F 18 injection for the detection of PSMA-positive lesions in patients with prostate cancer.
Based on results from the OSPREY...
03/11/2026
Radiopharmaceutical Education Institute
Bertrand Tombal, MD, PhD
Videos
03/05/2026
Bertrand Tombal, MD, PhD
Bertrand Tombal, MD, PhD, discusses final overall survival results from the EORTC 1333/PEACE-3 trial evaluating enzalutamide with or without radium-223 in patients with metastatic castration-resistant prostate cancer and bone metastases.
Bertrand Tombal, MD, PhD, discusses final overall survival results from the EORTC 1333/PEACE-3 trial evaluating enzalutamide with or without radium-223 in patients with metastatic castration-resistant prostate cancer and bone metastases.
Bertrand Tombal, MD, PhD,...
03/05/2026
Radiopharmaceutical Education Institute
Alexander Wyatt, PhD
Videos
02/26/2026
Alexander Wyatt, PhD
Alexander Wyatt, PhD, discusses results from a post hoc correlative analysis of the phase 2 TheraP trial comparing 177Lu-PSMA-617 with standard cabazitaxel chemotherapy in patients with metastatic castration-resistant prostate cancer.
Alexander Wyatt, PhD, discusses results from a post hoc correlative analysis of the phase 2 TheraP trial comparing 177Lu-PSMA-617 with standard cabazitaxel chemotherapy in patients with metastatic castration-resistant prostate cancer.
Alexander Wyatt, PhD, discusses...
02/26/2026
Radiopharmaceutical Education Institute
Scott Tagawa, MD
Videos
10/30/2025
Scott Tagawa, MD
Scott Tagawa, MD, Weill Cornell Medicine, discusses results from the phase 3 PSMAddition trial evaluating the addition of 177Lu-PSMA-617 to androgen deprivation therapy and androgen receptor pathway inhibitor therapy for patients with...
Scott Tagawa, MD, Weill Cornell Medicine, discusses results from the phase 3 PSMAddition trial evaluating the addition of 177Lu-PSMA-617 to androgen deprivation therapy and androgen receptor pathway inhibitor therapy for patients with...
Scott Tagawa, MD, Weill Cornell...
10/30/2025
Radiopharmaceutical Education Institute
News
10/19/2025
Stephanie Holland
Adding 177Lu-PSMA-617 to standard androgen deprivation therapy plus an androgen receptor pathway inhibitor significantly improved radiographic PFS in metastatic hormone-sensitive prostate cancer, according to a second interim analysis from...
Adding 177Lu-PSMA-617 to standard androgen deprivation therapy plus an androgen receptor pathway inhibitor significantly improved radiographic PFS in metastatic hormone-sensitive prostate cancer, according to a second interim analysis from...
Adding 177Lu-PSMA-617 to...
10/19/2025
Radiopharmaceutical Education Institute
FDA Approval
03/28/2025
Stephanie Holland
Based on results from the PSMAfore trial, the FDA has expanded the approval of lutetium Lu 177 vipivotide tetraxetan to include patients with PSMA-positive metastatic castration-resistant prostate cancer previously treated with ARPIs and...
Based on results from the PSMAfore trial, the FDA has expanded the approval of lutetium Lu 177 vipivotide tetraxetan to include patients with PSMA-positive metastatic castration-resistant prostate cancer previously treated with ARPIs and...
Based on results from the...
03/28/2025
Radiopharmaceutical Education Institute
Conference Coverage
02/13/2025
Allison Casey
The addition of [177Lu]Lu-PSMA-617 to enzalutamide improved the overall survival and several quality-of-life measures among patients with poor-risk, metastatic castration-resistant prostate cancer.
The addition of [177Lu]Lu-PSMA-617 to enzalutamide improved the overall survival and several quality-of-life measures among patients with poor-risk, metastatic castration-resistant prostate cancer.
The addition of...
02/13/2025
Oncology
Philip Kuo, MD, PhD, University of Arizona Cancer Center
Videos
11/10/2023
Philip Kuo, MD, PhD
Philip Kuo, MD, PhD, shares results from a sub-study of the phase 3 VISION trial, investigating the association between baseline PSMA expression and response to 177Lu-PSMA-617 therapy among patients with metastatic castration-resistant...
Philip Kuo, MD, PhD, shares results from a sub-study of the phase 3 VISION trial, investigating the association between baseline PSMA expression and response to 177Lu-PSMA-617 therapy among patients with metastatic castration-resistant...
Philip Kuo, MD, PhD, shares...
11/10/2023
Oncology
News
11/06/2023
Allison Casey
A phase 2 study found that adding adaptive-dosed 177Lu-PSMA-617to enzalutamide improved several PSA-based outcomes among patients with metastatic castration-resistant prostate cancer.
A phase 2 study found that adding adaptive-dosed 177Lu-PSMA-617to enzalutamide improved several PSA-based outcomes among patients with metastatic castration-resistant prostate cancer.
A phase 2 study found that...
11/06/2023
Oncology
Oliver Sartor, MD, Mayo Clinic
Videos
10/25/2023
Oliver Sartor, MD
At the 2023 ESMO Congress, Oliver Sartor, MD, described results from the phase 3 PSMAfore trial evaluating 177Lu-PSMA-617 vs androgen receptor-directed therapy for taxane-naive patients with metastatic castration-resistant prostate cancer.
At the 2023 ESMO Congress, Oliver Sartor, MD, described results from the phase 3 PSMAfore trial evaluating 177Lu-PSMA-617 vs androgen receptor-directed therapy for taxane-naive patients with metastatic castration-resistant prostate cancer.
At the 2023 ESMO Congress,...
10/25/2023
Oncology