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- In this educational initiative, focusing on the knowledge of PSMA PET and PSMA theranostics, Jeremie Calais presents on understanding the physiological PSMA biodistribution and the pathological uptake of the use of PSMA for prostate cancer. Independent Medical Education Initiative Supported by Novartis/Adacap and Point Biopharma Biographies: Jeremie Calais, MD, MSc, Director, Clinical Research Pro...
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- The CONDOR trial was one of two studies that supported the United States Federal Drug Administration (FDA) submission and subsequent approval of DCFPyL, an 18F radiolabeled PSMA directed PET tracer. The CONDOR trial focused specifically on the rising, the biochemically relapsed patient population, those who had surgery or radiation as their definitive primary therapy, biochemically relapsed, and t...
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- In this UroToday Journal Club, Christopher Wallis and Zachary Klaassen discuss the Clinical Cancer Research publication on the results from the CONDOR Phase 3, multicenter study. In particular, conventional imaging performs poorly when PSA levels are low, less than 2 ng/mL, and the use of novel PET radiotracers may address this issue and provide more sensitive imaging. CONDOR was a prospective stu...
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- Michael Morris, MD joins Charles Ryan, MD in a discussion on the United States (US) FDA Approval of PYLARIFY®, an F 18-labeled prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. The F 18 tracer went through two qualifying clinical trials the CONDOR trial and then OSPREY trial. This is the first time a national commercial approval will render PSMA i...
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- On December 1, 2020, the US Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) for use for patients with suspected prostate cancer metastasis in UCLA and UCSF. It is the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. In a follow-up conversation after speaking about the approv...
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- Jeremie Calais, MD, MSc, joins Phillip Koo, MD, FACS, to discuss the approval of Gallium 68 PSMA-11, the first agent for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. The safety and efficacy of Ga 68 PSMA-11 were evaluated in two prospective clinical trials, which lead to the United States Federal Drug Administ...
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- 68 Ga-PSMA-11, the first drug for PET imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer (PC), was FDA approved on December 1, 2020. The approval was granted to the University of California–San Francisco (UCSF) and UC–Los Angeles (UCLA). 68 Ga-PSMA-11 is indicated for suspected metastatic disease at the time of initial staging prior to definitive ther...
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- Prostate Cancer Outreach Webinar - Hosted by The Society of Nuclear Medicine and Molecular Imaging (SNMMI)'s Prostate Cancer Working Group, and faculty from the University of California, San Francisco (UCSF) Molecular imaging and radionuclide therapies play an important role in the management of patients with prostate cancer. Recent advances are allowing for increased precision in both diagnosis a...
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- Michael Morris, Oliver Sartor, and Alicia Morgans discuss the CONDOR study, the second of two prospective clinical trials designed in collaboration with the FDA to demonstrate the diagnostic performance of PyL in patients with biochemically recurrent prostate cancer. Correct localization rate (CLR), or the positive predictive value of the PyL scan, was established as the primary endpoint and the C...
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- Declan Murphy and Michael Hofman join Alicia Morgans to discuss the results from proPSMA study "A prospective randomized multi-center study of the impact of Ga-68 PSMA-PET/CT imaging for staging high-risk prostate cancer prior to curative-intent surgery or radiotherapy." Conventional imaging using CT and bone scan has insufficient sensitivity when staging men with high-risk localized prostate canc...
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