Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study

Morris, Michael J.; Rowe, Steven P.; Gorin, Michael A.; Saperstein, Lawrence; Pouliot, Frédéric; Josephson, David; Wong, Jeffrey Y.C.; Pantel, Austin R.; Cho, Steve Y.; Gage, Kenneth L.; Piert, Morand; Iagaru, Andrei; Pollard, Janet H.; Wong, Vivien; Jensen, Jessica; Lin, Tess; Stambler, Nancy; Carroll, Peter R.; Siegel, Barry A.

doi:10.1158/1078-0432.ccr-20-4573

Cited by 209 publications

(182 citation statements)

References 34 publications

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“…As the evidence continues to build, policies are quickly changing. For example, in the United States, the first PSMA PET radiotracer 18F-DCPyL was approved by the FDA for commercial use on May 27, 2021 based on findings from prospective phase 2/3 trials OSPREY and CONDOR ( 13 , 14 ).…”

Section: Discussionmentioning

confidence: 99%

Establishing a Provincial Registry for Recurrent Prostate Cancer: Providing Access to PSMA PET/CT in Ontario, Canada

et al. 2021

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Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is becoming established as a standard of care for the (re)staging of high-risk primary and prostate cancer recurrence after primary therapy. Despite the favorable performance of this imaging modality with high accuracy in disease detection, the availability of PSMA PET/CT varies across jurisdictions worldwide due to variability in the selection of PSMA PET/CT agent, regulatory approvals and funding. In Canada, PSMA based radiopharmaceuticals are still considered investigational new drug (IND), creating limitations in the deployment of these promising imaging agents. While regulatory approval rests with Health Canada, as a single payer health system, funding for Health Canada approved drugs and devices is decided by Provincial Health Ministries. Ontario Health (Cancer Care Ontario) (OH-CCO) is the agency of the Ministry of Health (MOH) in Ontario responsible for making recommendations to the MOH around the organization and funding of cancer services within Ontario (population of 15 million), and the PET Steering Committee of OH-CCO is responsible for providing recommendations on the introduction of new PET radiopharmaceuticals and indications. For Health Canada approved PET radiopharmaceuticals like 18F-FDG, OH-CCO (on behalf of the MOH) provides coverage based on levels of evidence and specific PET Registries are established to aid in real-world evidence collection to inform OH-CCO regarding emerging PET applications. In the case of PSMA PET/CT, adapting this model to an IND PSMA PET/CT agent, 18F-DCFPyL, necessitated the creation of a hybrid Registry-Study model to leverage the existing OH-CCO Registry structure while respecting the need for a Health Canada Clinical Trials Application (CTA) for the deployment of this agent in the province. Within the first 2 years of the registry, over 1700 men have been imaged resulting in a change in management (compared to pre-PET management plans) in over half of the men imaged. In this article, we describe the organization and deployment of the PSMA PET/CT (PREP) Registry throughout the province to provide access for men with suspected prostate cancer recurrence along with key stakeholder perspectives and preliminary results.

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Section: Discussionmentioning

confidence: 99%

Establishing a Provincial Registry for Recurrent Prostate Cancer: Providing Access to PSMA PET/CT in Ontario, Canada

et al. 2021

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“…of the CONDOR phase 3 trial [61]. In this trial of 208 men with biochemically recurrent prostate cancer and equivocal findings on conventional imaging, 18 F-DCFPyL correctly localized disease in 85% of patients and changed management in 64%.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

CAR T-Cell Therapy: An Update for Radiologists

Yoon

Smith

Tirumani

et al. 2021

American Journal of Roentgenology

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The publication of this Accepted Manuscript is provided to give early visibility to the contents of the article, which will undergo additional copyediting, typesetting, and review before it is published in its final form. During the production process, errors may be discovered that could affect the content of the Accepted Manuscript. All legal disclaimers that apply to the journal pertain. The reader is cautioned to consult the definitive version of record before relying on the contents of this document.

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“…In 208 patients with BCR (PSA ranging between 0.2 and 98.4 ng/mL) and negative standard imaging the performance of PSMA PET/CT (CONDOR study) was found to determine a correct localization rate of 84.8-87.0%. Interestingly 63.9% of evaluable patients had a change in intended management after PSMA PET/CT (59).…”

Section: Imaging and Genetic Testing Before Art/srtmentioning

confidence: 99%

Radiation Therapy After Radical Prostatectomy: What Has Changed Over Time?

et al. 2021

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The role and timing of radiotherapy (RT) in prostate cancer (PCa) patients treated with radical prostatectomy (RP) remains controversial. While recent trials support the oncological safety of early salvage RT (SRT) compared to adjuvant RT (ART) in selected patients, previous randomized studies demonstrated that ART might improve recurrence-free survival in patients at high risk for local recurrence based on adverse pathology. Although ART might improve survival, this approach is characterized by a risk of overtreatment in up to 40% of cases. SRT is defined as the administration of RT to the prostatic bed and to the surrounding tissues in the patient with PSA recurrence after surgery but no evidence of distant metastatic disease. The delivery of salvage therapies exclusively in men who experience biochemical recurrence (BCR) has the potential advantage of reducing the risk of side effects without theoretically compromising outcomes. However, how to select patients at risk of progression who are more likely to benefit from a more aggressive treatment after RP, the exact timing of RT after RP, and the use of hormone therapy and its duration at the time of RT are still open issues. Moreover, what the role of novel imaging techniques and genomic classifiers are in identifying the most optimal post-operative management of PCa patients treated with RP is yet to be clarified. This narrative review summarizes most relevant published data to guide a multidisciplinary team in selecting appropriate candidates for post-prostatectomy radiation therapy.

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Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study

Cited by 209 publications

References 34 publications

Establishing a Provincial Registry for Recurrent Prostate Cancer: Providing Access to PSMA PET/CT in Ontario, Canada

Establishing a Provincial Registry for Recurrent Prostate Cancer: Providing Access to PSMA PET/CT in Ontario, Canada

CAR T-Cell Therapy: An Update for Radiologists

Radiation Therapy After Radical Prostatectomy: What Has Changed Over Time?

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