Emory Urology Prostate Cancer Research & Clinical Trials

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:

• Histologically confirmed adenocarcinoma of the prostate

• Candidate for RP with PLND scheduled to undergo the surgical procedure

• Unfavorable intermediate-risk (Gleason Grade Grouping [GGG] 2 with ≥50% of biopsy cores

• 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:

• Patients who are planned to have an x-ray contrast agent or other PET radiotracer

Principal Investigator:

David Schuster, MD

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

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:

• 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

• 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:

• Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan

• Patients currently receiving ADT

Principal Investigator: 

David Schuster, MD

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

Biomarkers and Clinical Parameters Associated with Gleason Score Upgrading

Inclusion Criteria:

• Biopsy-proven Gleason 3+3=6 prostate cancer diagnosed within the past two years

• Patient scheduled for radical prostatectomy

Exclusion Criteria:

• Gleason score greater than 3+3=6 on any prior prostate biopsy

• Any treatment other than radical prostatectomy planned for prostate cancer

• Prior treatment of the prostate with androgen deprivation, radiation, or other cytotoxic chemotherapy

Principal Investigator: 

Martin Sanda, MD

Co-Investigator & Collaborator: 

John Pattaras, MD

Canary Prostate Active Surveillance Study Protocol

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate

• Clinically localized prostate cancer: T1-2; NX or N0, MX or M0

• No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy)

• 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:

• Unwillingness or inability to undergo serial prostate biopsy

• 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: 

Christopher Filson, MD

Co-Investigators & Collaborators: 

Martin Sanda, MD; John Pattaras, MD

EDRN Prostate MRI Biomarker Study and Reference Set

Inclusion Criteria:

• 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:

• Prior diagnosis of prostate cancer

• Prior prostate biopsy or failure to conduct the study

• Prior prostate MRI

Principal Investigator: 

Christopher Filson, MD

Co-Investigators: 

Martin Sanda, MD; Aaron Lay, MD; Cara Cimmino, MD

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:

• 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

• Able to tolerate androgen deprivation therapy (ADT) for up to one year

Exclusion Criteria:

• Distant metastasis (clinical stage M1)

• Prior androgen deprivation therapy (ADT)

Principal Investigator: 

John Pattaras, MD

Co-Investigator & Collaborator: 

Omer Kucuk, MD (Department of Hematology and Medical Oncology)