Prostate Cancer Research & Clinical Trials

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)
  – Abnormal DRE

Exclusion Criteria:

• Prior diagnosis of prostate cancer

• Prior prostate biopsy or failure to conduct the study biopsy

• Prior prostate MRI unless marked for fusion biopsy

Principal Investigator:

Christopher Filson, MD

Co-Investigators:

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

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Inclusion Criteria:

• Proven diagnosis of adenocarcinoma of the prostate (patients with oligometastatic prostate cancer may receive metastasis directed therapy prior to randomization — up to 4 sites)

• Must have a bone scan and either a CT of abdomen and pelvis or MRI of pelvis within 42 days prior to starting standard systemic therapy (SST)

Exclusion Criteria:

• No known brain metastases

• No prior malignancy

• Exceptions: Adequately treated basal cell/squamous cell skin cancer, Stage 0-II cancer from which the patient is in complete remission, or any other cancer from which patient is disease free for 3 years

Principal Investigator: 

Shreyas Joshi, MD

Co-Investigators:

Christopher Filson, MD, Lindsey Hartsell, MD, Aaron Lay, MD, Viraj Master, MD, PhD, Kenneth Ogan, MD, John Pattaras, MD, Martin Sanda, MD,

Department of Hematology and Medical Oncology: Mehmet Bilen, MD, Joan Cain MD, Bradley Carthon, MD, PhD, Christine Ertley, PA, Meredith Foushee, PA, Sarah Friend, MD, Jamie Goldman, MD, Andrea Huffman, PA-C, Omer Kucuk, MD, David Lawson, MD, Bassel Nazha, MD, Neela Natarajan, MD, Stephen Szabo, MD,

Department of Radiation Oncology: Sheela Hanasoge, MBBS, PhD, Bruce Hershatter, MD, Ashesh Jani, MD, Joseph Shelton, MD,

Department of Medical Oncology: Julia Green, NP, Greta Russler MSN, FNP-BC, Lauren Yantorni, NP