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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer (ARASTEP)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine if darolutamide plus ADT given for 12 months improves rPFS by PSMA PET/CT compared with placebo plus ADT given for 12 months, and to further evaluate efficacy and to measure the treatment impact on patients’ quality of life, and to assess the safety of darolutamide plus ADT compared with placebo plus ADT.
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Intra-patient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
Jacksonville, Fla.
The purpose of this study is to compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
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MC230502 Dynamic InVestigator INitiated Enterprise (DIVINE) in Prostate Cancer (DIVINE)
Rochester, Minn.
Prostate cancer is one of the most prevalent malignancies affecting men worldwide, ranging from localized tumors to aggressive, metastatic disease (Siegel et al. 2023). An enormous array of treatments is available for treating prostate cancers, but the field faces a critical challenge in the lack of reliable biomarkers across the spectrum of disease that can direct treatment. This challenge is especially pressing in the current landscape where novel therapeutic approaches and personalized treatments are transforming prostate cancer for our patients.
This clinical trial aims to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) across time and treatments. Critically, we seek to define these questions for patients among under-represented populations in this multi-group, multi-department, multi-center, investigator-initiated trial.
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Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study (CLARIFY)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
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Integration of PSMA PET imaging and Extracellular Vesicle-Based Tumor Monitoring for Biochemically Recurrent Prostate Cancer
Scottsdale/Phoenix, Ariz.
The purpose of this study is to develop an inexpensive and non-invasive blood test that can help refine the identification of patients with PSMA-positive metastatic lesions following biochemical recurrence.
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Intra-patient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
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MC230502 Dynamic InVestigator INitiated Enterprise (DIVINE) in Prostate Cancer (DIVINE)
Scottsdale/Phoenix, Ariz.
Prostate cancer is one of the most prevalent malignancies affecting men worldwide, ranging from localized tumors to aggressive, metastatic disease (Siegel et al. 2023). An enormous array of treatments is available for treating prostate cancers, but the field faces a critical challenge in the lack of reliable biomarkers across the spectrum of disease that can direct treatment. This challenge is especially pressing in the current landscape where novel therapeutic approaches and personalized treatments are transforming prostate cancer for our patients.
This clinical trial aims to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) across time and treatments. Critically, we seek to define these questions for patients among under-represented populations in this multi-group, multi-department, multi-center, investigator-initiated trial.
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