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Prostate Cancer Trials

For enrollment information involving the following trials, please contact one of the research staff members on the "Meet the Team" page.

Screening Preparation Tool (PCSPrep)

Decision Making (P3-P)

Imaging Outcome Study (FACBC PET-CT)

Imaging Study (FACBC PET)

Tissue Bank

SCREENING PREPARATION TOOL (PCSPrep)

This study utilizes eHealth Technology as a tool to standardize prostate cancer information conveyed to men eligible for prostate cancer screening. The purpose of the study is to standardize the process and minimize disparities in the information so that men are better equipped to make appropriate informed decisions.

Eligibility:

• African American men eligible for prostate cancer screening
• 40-70 years of age
• English speaking

Exclusion Criteria:

• History of prostate cancer screening within the past five years
• Established diagnosis of prostate cancer
• Psychiatric illnesses (major)
• Cognitive challenges/impairment

Principal Investigator: Dr. Martin Sanda

Co-Investigator & Collaborator: Dr. Viraj Master

DECISION MAKING (P3-P)

Personal Patient Profile – Prostate (P3-P) II: An Effectiveness-Implementation Trial in Diverse Health Care Networks.

Eligibility:

• Recent biopsy proving diagnosis of prostate cancer, T1 or T2 of any risk level
• No managment decisions or plans have been formulated or implemented
• Has made an appointment with a consulting specialist at enrolling study site
• Able to read, write, and understand English

Exclusion Criteria:

• Multiple post biopsy consult visits to specialists
• Active survelleince for prostate cancer
• Treatment for prostate cancer

Treatment:

This is a trial to assess the effectiveness of a decision support tool, the Personal Patient Profile, for men who are making decisions about their treatment and care for localized prostate cancer.

Principal Investigator: Dr. Martin Sanda

Co-Investigator & Collaborator: Dr. Viraj Master

IMAGING OUTCOME STUDY (FACBC PET-CT)

Advanced molecular imaging with anti-3-[18F]FACBC PET-CT to improve the selection and outcomes of prostate cancer patients receiving post-prostatectomy radiotherapy.

Inclusion Criteria:

• Adenocarcinoma of the prostate, post radical-prostatectomy
• Detectable PSA
• ECOG/Zubrod Performance Status of 0-2
• Negative technetium 99-m MDP or F-18 PET bone scan for skeletal metastasis
• CT or MR scan of abdomen and pelvis which does not suggest presence of metastatic disease outside of the pelvis
• Willingness to undergo pelvic radiotherapy

Exclusion Criteria:

• Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiation)
• Inability to undergo anti-3-[18F]FACBC PET-CT
• Age under 18
• Metastatic disease outside of pelvis on any imaging or biopsy
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of three years
• Severe acute co-morbidities, defined as follows:
   - Unstable angina and/or congestive heart failure requiring hospitalization in the last three months
   - Transmural myocardial infarction within the last six months
   - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
   - Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
   - Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol

Excluding patients with AIDS from this protocol is necessary because the treatments involved may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.

Treatment:

Patients will be randomized to:

Arm A: The control group whose treatment decisions will be made based on conventional imaging (bone scan and abdominopelvic CT scan); or

Arm B: The trial group in which anti-3-[18F]FACBC PET-CT is used to guide radiotherapy decisions and radiotherapy treatment volumes.

Eligible Treatment Centers

• The Emory Clinic
• Emory University Hospital
• Emory Saint Joseph's Hospital
• Emory Midtown Hospital
• Grady Memorial Hospital
• Winship Cancer Institute

Sponsor: NIH (RO1)

Principal Investigator: Dr. Ashesh Jani (Department of Radiation Oncology)

Co-Investigators & Collaborators: Dr. Viraj Master, Dr. Peter Nieh

IMAGING STUDY (FACBC PET)

Transmolecular imaging of recurrent prostate carcinoma with exploration of genomic markers differences between local and distant recurrence.

Eligibility:

• Patients originally diagnosed with localized (T1c, T2 or T3) prostate cancer who had definitive therapy for prostate cancer (brachytherapy, cryotherapy, or external beam radiation therapy) but not prostatectomy
• Rising PSA resulting in suspicion that prostate cancer has returned

Exclusion criteria:

• Less than one year since cryotherapy or two years since brachytherapy or external beam radiation
• Bone scan finding indicate metastatic prostate cancer 

Treatment:

After routine imaging studies (bone scan, CT pelvis, Prostascint scan), FACBC PET scan will be performed. Then, active sites within prostate bed or extraprostatic will be biopsied.

Sponsor: NIH

Principal Investigator: Dr. David Schuster (Department of Radiology and Imaging Services)

Co-Investigators & Collaborators: Dr. Peter Nieh, Dr. Viraj Master

TISSUE BANK

Prostate tissue and specimen bank at Emory University and affiliated medical centers.

Eligibility:

• Male undergoing prostate cancer screening or prostate cancer treatment.

Eligible Treatment Centers:

• Emory University Hospital
• The Emory Clinic
• Emory Saint Joseph's Hospital
• Emory Midtown Hospital
• Grady Memorial Hospital

Exclusion Criteria:

• None

Other Information:

• Following surgical removal, all tissue will be processed by the pathology department for routine standard histopathological examination. For the tissue Bank, a small portion of the tissue will be used for research testing.
• Additional specimens such as blood, urine, and saliva may be collected for research purposes.
• Patient medical records and test results will be reviewed and compiled in a relational database for research analysis.

Principal Investigator: Dr. John Petros

Co-Investigators & Collaborators: Dr. Martin Sanda, Dr. Viraj Master, Dr. Adeboye Osunkoya (Department of Pathology and Laboratory Medicine), Dr. Joseph Shelton (Department of Radiation Oncology)

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