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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
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    Ph III SST v Standard Systemic Plus Definitive Rx(Surgery or Radiation)Primary Tumor Met Prostate Ca

    Protocol: SWOG-S1802

    Principal Investigator: Steven K Clinton, MD, PhD

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    Phase III IGRT & SBRT Vs IGRT & Hypofractionated IMRT For Localized Intermediate Risk Prostate Cance

    Protocol: NRG-GU005

    Principal Investigator: Dayssy Diaz Pardo, MD

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    Ph2, DB, Plac-Cont, Rnd Tr Salvage RT w or w/o Enh Anti-Andro Ther w Apalutamide in Rec Prostate Ca

    Protocol: NRG-GU006

    Principal Investigator: Dayssy Diaz Pardo, MD

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    Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients with Prostate Cancer

    Protocol: RTOG-0924


    Inclusion Criteria:

    Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:

    Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)

    Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml

    Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL

    Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure

    History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration

    Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal computed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, or dissection) within 90 days prior to registration

    Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.5 cm

    No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute)

    Equivocal bone scan findings are allowed if plain films (or CT or magnetic resonance imaging [MRI]) are negative for metastasis

    Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration

    Study entry PSA should not be obtained during the following time frames:

    10-day period following prostate biopsy

    Following initiation of hormonal therapy

    Within 30 days after discontinuation of finasteride

    Within 90 days after discontinuation of dutasteride

    Zubrod performance status 0-1 (unless otherwise specified)

    Absolute neutrophil count (ANC) >= 1,500/mm³

    Platelets >= 100,000/mm³

    Hemoglobin (Hgb) >= 8.0 g/dL (Note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable)

    Patient must be able to provide study specific informed consent prior to study entry

    Exclusion Criteria:

    Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1095 days) not in the pelvis (for example, carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy not allowed

    Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

    Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

    Previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)

    Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is =< 45 days prior to the date of registration

    Use of finasteride within 30 days prior to registration

    Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

    Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable

    Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields

    Severe, active co-morbidity, defined as follows:

    Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    Transmural myocardial infarction within the last 6 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

    Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction

    Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients

    Patients who are sexually active and not willing/able to use medically acceptable forms of contraception

    Prior allergic reaction to the hormones involved in this protocol

    Patients status post a negative lymph node dissection are not eligible

    Principal Investigator: Dayssy Diaz Pardo, MD

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  • open for enrollment

    3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer

    Protocol: OSU-07042


    Inclusion Criteria:

    Patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (Gleason’s score >= 7 and prostate-specific antigen [PSA] of > 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians

    Written informed consent will be signed by the patients before the MRI based on the guidelines approved by the Ohio State University Institutional Review board

    Patients must have an estimated glomerular filtration rate of >= 30 mL/min/1.73m^2 within six weeks of the MRI to be included in the study

    Exclusion Criteria:

    Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)

    Subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged

    Subjects that have vascular or aneurysm clips, or metallic staples from a surgical procedure

    Subjects with permanent tattoo eye liner (may contain metallic coloring)

    Subjects that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims

    Subjects that exhibit noticeable anxiety and/or claustrophobia

    Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher

    Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)

    Subjects with an estimated glomerular filtration rate of < 30 mL/min/1.73m^2 within six weeks of the MRI

    Acute or chronic severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73m^2)

    Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period

    Principal Investigator: Michael V Knopp, MD, PhD

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  • open for enrollment

    The Effect of a Soy Bread Diet Intervention on Immune Function in Men with Prostate Cancer

    Protocol: OSU-12042

    Principal Investigator: Steven K Clinton, MD, PhD

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