BED-PSMA 301
Prospective, Phase 3, Multi-Center, Single-Arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA-7.3 (18F) PET Ligand in Men With Newly Diagnosed Prostate Cancer
Inclusion Criteria:
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Histologically confirmed adenocarcinoma of the prostate
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Candidate for RP with PLND scheduled to undergo the surgical procedure
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Unfavorable intermediate-risk (Gleason Grade Grouping [GGG] 2 with ≥50% of biopsy cores
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Positive for PCa and/or >1 Intermediate Risk Factor [T2b; T2c; PSA 10-20] or Any GGG 3) or high-risk or very high-risk disease (per NCCN Guidelines Version 2.2019; PROS-2)
Exclusion Criteria:
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Patients who are planned to have an x-ray contrast agent or other PET radiotracer
Principal Investigator:
Co-Investigators & Collaborators:
Yoram Baum, MD (Department of Radiology and Imaging Sciences); Christopher Filson, MD; Raghuveer Halkar, MD (Department of Radiology and Imaging Sciences); Shreyas Joshi, MD, MPH; Aaron Lay, MD; Kenneth Ogan, MD; John Pattaras, MD; Martin Sanda, MD
BED-PSMA 302
Prospective, Phase 3, Multi-Center, Single-Arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA-7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy
Inclusion Criteria:
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History of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of PCa, following prior treatment with one or more of the following:
(a) RP
(b) RP plus adjuvant RT
(c) RP plus adjuvant androgen deprivation therapy (ADT)
(d) external beam radiation therapy
(e) focal gland therapies (e.g. brachytherapy, high-intensity focused ultrasound [HIFU]). -
If previously taking ADT, it should have been discontinued at least 16 weeks prior to screening
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An elevated PSA, clinically suspicious for biochemically recurrent disease:
– Following RP: initial PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL
– Following RT: nadir +2 ng/mL
– Following focal gland therapies: nadir +2 ng/mL
Exclusion Criteria:
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Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan
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Patients currently receiving ADT
Principal Investigator:
Co-Investigators & Collaborators:
Yoram Baum, MD (Department of Radiology and Imaging Sciences); Mehmet Bilen, MD (Department of Hematology and Medical Oncology); Bradley Carthon, MD (Department of Hematology and Medical Oncology); Christopher Filson, MD; Benjamin Fischer-Valuck, MD (Department of Radiation Oncology); Raghuveer Halkar, MD (Department of Radiology and Imaging Sciences); Bruce Hershatter, MD (Department of Radiation Oncology); Ashesh Jani, MD (Department of Radiation Oncology); Shreyas Joshi, MD, MPH; Omer Kucuk, MD (Department of Hematology and Medical Oncology); Aaron Lay, MD; Kenneth Ogan, MD; Sagar Patel, MD (Department of Radiation Oncology); Pretesh Patel, MD (Department of Radiation Oncology); John Pattaras, MD; Martin Sanda, MD
EDRN Upgrading Study
Biomarkers and Clinical Parameters Associated with Gleason Score Upgrading
Inclusion Criteria:
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Biopsy-proven Gleason 3+3=6 prostate cancer diagnosed within the past two years
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Patient scheduled for radical prostatectomy
Exclusion Criteria:
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Gleason score greater than 3+3=6 on any prior prostate biopsy
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Any treatment other than radical prostatectomy planned for prostate cancer
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Prior treatment of the prostate with androgen deprivation, radiation, or other cytotoxic chemotherapy
Principal Investigator:
Co-Investigator & Collaborator:
EDRN Pass
Canary Prostate Active Surveillance Study Protocol
Inclusion Criteria:
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Histologically confirmed adenocarcinoma of the prostate
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Clinically localized prostate cancer: T1-2; NX or N0, MX or M0
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No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy)
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Prostate biopsy requirements: (A) If diagnosis within one year of baseline visit, participants must have at least one biopsy within at least 10 cores; (B) If diagnosis more than one year prior to baseline visit, participants must have a minimum of two biopsies, one of which must be within two years prior to baseline visit
Exclusion Criteria:
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Unwillingness or inability to undergo serial prostate biopsy
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History of other malignancies, except: Adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for > five years
Principal Investigator:
Co-Investigators & Collaborators:
EDRN MRI
EDRN Prostate MRI Biomarker Study and Reference Set
Inclusion Criteria:
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Men with suspected but undiagnosed prostate cancer
– Abnormal laboratory test for prostate cancer that indicates elevated risk including:
– e.g., PSA, - % free PSA, abnormal 4K, PHI, exosome, SelectMDx
– Elevated PSA velocity
– Lower PSA value with other risk factors for PCa (e.g., family history)
Exclusion Criteria:
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Prior diagnosis of prostate cancer
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Prior prostate biopsy or failure to conduct the study
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Prior prostate MRI
Principal Investigator:
Co-Investigators:
Janssen PROTEUS
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
Inclusion Criteria:
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Histologically confirmed adenocarcinoma of the prostate meeting one of the below criteria:
– Any combination of Gleason 4+3 and Gleason 4+4 or 5+3 from at least six systemic cores
– Any combination of Gleason 4+3 and Gleason 4+4 or 5+3 from at least three systemic cores with PSA above or equal to 20
– Gleason 9 or above in one systemic/targeted core
– At least two systematic or targeted cores with continuous Gleason 8 or above, each with at least 80% involvement -
ECOG 0 or 1
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Able to tolerate androgen deprivation therapy (ADT) for up to one year
Exclusion Criteria:
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Distant metastasis (clinical stage M1)
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Prior androgen deprivation therapy (ADT)
Principal Investigator:
Co-Investigator & Collaborator:
Omer Kucuk, MD (Department of Hematology and Medical Oncology)