Prostate Cancer Research & Clinical Trials

A Phase 4 Open-Label Multicenter Study of PYLARIFY® PET/CT or PET/MRI in Men with Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer 

Inclusion Criteria:

• Patients must be ≥18 years of age 

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 

• Patients with life expectancy of at least 13 months as determined by the investigator 

• Patients must have histopathologically confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate.  

• Note: Date of the prostate biopsy should be no sooner than 2 weeks and no later than 3 months prior to PYLARIFY PET imaging 

Exclusion Criteria:

• Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1 

• Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy 

• Known hypersensitivity to the components of PYLARIFY or its analogs 

• Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study 

• Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed) 

Principal Investigator: 

Shreyas Joshi, MD

An Open-Label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients 

Inclusion Criteria:

• Male subjects aged > 18 years. 

• Patients with confirmed Gleason score of 8 – 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy. 

• Ability to lie still for MRI scanning. 

• Patients must be able to provide written informed consent. 

• Creatinine ≤ 1.2 mg/dL; glomerular filtration rate (GFR) ≥ 60 mL/min within a 30 days of the research MRI. 

Exclusion Criteria:

• Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease. 

• Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections. 

• Patients with uncontrolled diabetes or hypertension. 

• Patients with active non-prostate malignancy. 

• Patients with contraindications for MRI including implantable pacemakers, cochlear implants. 

• Patients with uni- or bilateral hip prosthesis. 

• Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments. 

• Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy. 

• Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result. 

• Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection. 

• Is determined by the investigator that the patient is clinically unsuitable for the study. 

• Participation in a concurrent clinical trial or in another trial within the past 30 days. 

Principal Investigator: 

David Schuster

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: 

Dr. Martin Sanda

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:

Dr. Martin Sanda

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

Improving Health Literacy in Newly Diagnosed Prostate Cancer Patients

Inclusion Criteria:

• Adults 18 years and older

• Provide informed consent

• Dx with Prostate cancer

Exclusion Criteria:

• History of dementia and cognitive impairment

• Patients with widely metastatic prostate cancer

• Patients with small cell cancer of the prostate

• All special populations are excluded: Adults unable to consent, Individuals who are not yet adults (infants, children, teenagers), Pregnant women, Imprisoned population, Cognitively impaired or Individuals with Impaired Decision-Making Capacity, and Individuals who are not able to clearly understand English

Principal Investigator: 

Viraj Master MD, PhD, FACS

A Phase 4 Open-Label Multicenter Study of PYLARIFY® PET/CT or PET/MRI in Men with Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer.

Inclusion Criteria:

• Patients must be ≥18 years of age

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Patients with life expectancy of at least 13 months as determined by the investigator

• Patients must have histopathologically confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate

• Note: Date of the prostate biopsy should be no sooner than 2 weeks and no later than 3 months prior to PYLARIFY PET imaging

Exclusion Criteria:

• Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1

• Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy

• Known hypersensitivity to the components of PYLARIFY or its analogs

• Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study

• Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)

Principal Investigator: 

Dr. Amol Takalkar

An Open-Label Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients.

Inclusion Criteria:

• Male subjects aged > 18 years

• Patients with confirmed Gleason score of 8 – 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy

• Ability to lie still for MRI scanning

• Patients must be able to provide written informed consent

• Creatinine ≤ 1.2 mg/dL; glomerular filtration rate (GFR) ≥ 60 mL/min within 30 days of the research MRI

Exclusion Criteria:

• Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease

• Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections

• Patients with uncontrolled diabetes or hypertension.

• Patients with active non-prostate malignancy

• Patients with contraindications for MRI including implantable pacemakers, cochlear implants

• Patients with uni- or bilateral hip prosthesis

• Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments

• Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy

• Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result.

• Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection

• Is determined by the investigator that the patient is clinically unsuitable for the study

• Participation in a concurrent clinical trial or in another trial within the past 30 days

Principal Investigator: 

Dr. David Schuster