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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.
  • open for enrollment

    Ph I Dose Escalation & Cohort Expansion Study of TSR-042 in Pts w/ Advanced Solid Tumors

    Protocol: OSU-16293

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Ph 1, BXQ-350 as a Single Agent by IV w/ Advanced Solid Tumors and Recurrent High-Grade Gliomas

    Protocol: OSU-16182

    Principal Investigator: Vinay K Puduvalli, MD

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  • open for enrollment

    Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

    Protocol: OSU-15244

    Eligibility:

    Inclusion Criteria:

    Histologically or cytologically-documented, advanced solid tumor of one of the

    following types:

    Anal Carcinoma

    Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or

    extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)

    Neuroendocrine Tumors (well- and moderately-differentiated) of the lung,

    appendix, small intestine, colon, rectum, or pancreas

    Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)

    Cervical Carcinoma

    Vulvar Carcinoma

    Small Cell Lung Carcinoma

    Mesothelioma

    Thyroid Carcinoma

    Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)

    OR

    Any advanced solid tumor, with the exception of colorectal carcinoma (CRC),

    which is Microsatellite Instability (MSI)-High (MSI-H)

    Progression of tumor or intolerance to therapies known to provide clinical benefit.

    There is no limit to the number of prior treatment regimens

    Can supply tumor tissue for study analyses (dependent on tumor type)

    Radiologically-measurable disease

    Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)

    Performance Scale

    Life expectancy of at least 3 months

    Adequate organ function

    Female participants of childbearing potential must be willing to use adequate

    contraception for the course of the study through 120 days after the last dose of

    study medication

    Male participants with partners of must childbearing potential must be willing to use

    adequate contraception for the course of the study through 120 days after the last

    dose of study medication

    Exclusion Criteria:

    Currently participating and receiving study therapy or has participated in a study of

    an investigational agent and received study therapy or used an investigational device

    within 4 weeks of the first dose of study medication

    Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form

    of immunosuppressive therapy within 7 days prior to the first dose of study

    medication

    Active autoimmune disease that has required systemic treatment in the past 2 years

    Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or

    not recovered from an adverse event caused by mAbs administered more than 4 weeks

    earlier

    Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2

    weeks of study Day 1 or not recovered from adverse events caused by a previously

    administered agent

    Known additional malignancy within 2 years prior to enrollment with the exception of

    curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the

    skin and/or curatively resected in situ cancers

    Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

    Has known glioblastoma multiforme of the brainstem

    History of non-infectious pneumonitis that required steroids or current pneumonitis

    Active infection requiring systemic therapy

    Known psychiatric or substance abuse disorders that would interfere with cooperation

    with the requirements of the study

    Pregnant, breastfeeding, or expecting to conceive or father children within the

    projected duration of the study, starting with the screening visit through 120 days

    after the last dose of study medication

    Previously participated in any other pembrolizumab (MK-3475) study, or received prior

    therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1),

    anti-PD-L2, or any other immunomodulating mAb or drug specifically targeting T-cell

    co-stimulation or checkpoint pathways

    Known history of Human Immunodeficiency Virus (HIV)

    Known active Hepatitis B or C

    Received live vaccine within 30 days of planned start of study medication

    Principal Investigator: Manisha H Shah, 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

    Eligibility:

    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

    Ph III Comparing ADT+TAK-700 w ADT+Bicalutamide in Newly Diagnosed Met Hormone Sensitive Prostate Ca

    Protocol: SWOG-S1216

    Eligibility:

    Inclusion Criteria:

    There are two patient populations eligible for the study: those who have not started any therapy with LHRH agonist or antagonist (or orchiectomy) (Early Induction Group) and those who have already started therapy with LHRH agonist or antagonist (or orchiectomy) within the 30 days prior to registration (Late Induction Group); patients must be registered within 30 days of first injection of the LHRH agonist or antagonist (or orchiectomy)

    Disease Related Criteria:

    All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate; all patients must have metastatic disease as evidenced by soft tissue and/or bony metastases prior to initiation of androgen deprivation therapy

    Patients who have not yet started androgen deprivation therapy (LHRH agonist/antagonist or orchiectomy) and will not have an LHRH agonist injection until after randomization (early induction group) must have radiographic assessments of all disease including bone scan (or positron emission tomography [PET] scan) within 42 days prior to registration; patients who have started androgen deprivation therapy (LHRH agonist/antagonist or orchiectomy) prior to registration (late induction group) must have radiographic assessments including bone scan (or PET scan) within 42 days prior to start of androgen deprivation therapy (if scans have not been obtained prior to LHRH agonist/antagonist or orchiectomy they must be done within 42 days prior to registration); all disease must be assessed and documented on the Baseline Tumor Assessment Form; NOTE: Androgen deprivation therapy does not include treatment with anti-androgens such as bicalutamide or flutamide or five alpha reductase inhibitors such as finasteride or dutasteride

    Patients with known brain metastases are not eligible; brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis; but, if brain imaging studies are performed, they must be negative for disease

    Patients who are deemed to have high-risk or extensive metastatic, hormone sensitive prostate cancer (mHSPC) per “clinical judgment” of the treating physician are eligible for enrollment if they are unsuitable candidates for docetaxel or if they have declined docetaxel therapy

    Prior Therapy Criteria:

    Patients may have received prior androgen deprivation therapy (ADT) - neoadjuvant and/or adjuvant setting only, but it must not have lasted for more than 36 months (note that this is NOT the same as “late induction” as described in Section 5.1b above); single or combination therapy allowed; at least 6 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting, and serum testosterone must be > 50 ng/dL (non-castrate levels) within 28 days prior to registration for early induction patients; Note: serum testosterone assessment is required for eligibility for only those with prior treatment with ADT

    Patients must not have received prior and/or must not have any plans for receiving concomitant therapy with ketoconazole, aminoglutethimide, or abiraterone acetate, or enzalutamide (MDV3100); concurrent megestrol for hot flashes is allowed

    Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer; prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed; at least 2 years must have elapsed since completion of cytotoxic chemotherapy in the neoadjuvant and/or adjuvant setting

    Patients may have received prior surgery; for all major surgeries, at least 14 days must have elapsed since completion and patient must have recovered from all major side effects of surgery per investigator’s assessment

    Patient may have received or plan to receive concurrent bone targeting agents that do not have an effect on PSA (e.g. denosumab or bisphosphonate)

    Patient must have no plans to receive any other experimental therapy while on the protocol treatment; previous experimental therapy must have been completed at least 28 days prior to registration

    In the late induction group, patients must have had no more than 30 days of prior castration (medical or surgical) for metastatic prostate cancer prior to registration; the start date of medical castration is considered the day the patient first received an injection of a LHRH agonist/antagonist (or orchiectomy), not an oral antiandrogen

    If the method of castration was luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide or goserelin), the patient must be willing to continue the use of LHRH agonist and add bicalutamide or TAK-700 (according to randomization) during protocol treatment

    If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization); there is no limit on how many days a patient may have been on an antiandrogen (e.g. bicalutamide, flutamide) or a five alpha reductase inhibitor (e.g. finasteride or dutasteride) prior to going on study and no washout is required

    If the method of castration was LHRH antagonists (i.e. Degarelix), the patient must be willing to switch to an LHRH agonist during protocol treatment

    Clinical/Laboratory Criteria:

    Patients must have a complete physical examination and medical history within 28 days prior to registration

    Patients must have a PSA >= 2 ng/mL obtained within 90 days prior to registration

    A dual-energy X-ray absorptiometry (DEXA) scan must be obtained within 2 years prior to registration

    Patients must not have New York Heart Association class III or IV heart failure at the time of screening; patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration (Note: Patients with congenital long AT syndrome, congestive heart failure, frequent electrolyte abnormalities, and patients taking drugs known to prolong the QT interval may be at increased risk)

    Patient must have a corrected QT interval (QTc) interval < 461 msec on the 12 lead electrocardiogram (ECG) within 42 days prior to registration, patients with asymptomatic or incidental bundle branch blocks may have QTc measured by a cardiologist or standard formulas such as Bazett’s or Fridericia’s to adjust for pre-existing blocks

    Patients must have a left ventricular ejection fraction (LVEF) >= 50% by echocardiogram or multiple gated acquisition (MUGA) scan within 42 days prior to registration

    Patients must have blood pressure measured within 14 days prior to registration; patients must not have uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart) despite appropriate medical therapy; Note: patients may be rescreened after adjustments of antihypertensive medications

    Bilirubin =< 2 x institutional upper limit of normal (ULN); these results must be obtained within 28 days prior to registration

    Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x institutional ULN, or =< 5 x institutional ULN if liver metastases are present; these results must be obtained within 28 days prior to registration

    Calculated creatinine clearance >= 40 mL/min using a serum creatinine or by 24-hour urine creatinine obtained within 28 days prior to registration

    Leukocytes >= 3,000/mcL; these results must be obtained within 28 days prior to registration

    Absolute neutrophil count (ANC) >= 1,500/mcL; these results must be obtained within 28 days prior to registration

    Hemoglobin >= 9 g/dL; these results must be obtained within 28 days prior to registration

    Platelets >= 100,000/mcL; these results must be obtained within 28 days prior to registration

    Patient must not be known to have human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with participation in this study; patients will be tested for hepatitis B or C or HIV infection during screening if they are considered by the investigator to be at higher risk for these infections and have not been previously tested

    Patients with a known history of primary and secondary adrenal insufficiency are not eligible

    Patient must not be known to have hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonist

    Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications per investigator’s clinical judgement

    Patients must have a Zubrod performance status of 0 - 2; Zubrod performance status 3 will be allowed if from bone pain only

    No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

    Men of reproductive potential and those who are surgically sterilized (i.e., post-vasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends

    Specimen Submission Criteria:

    Patients must be offered the opportunity to participate in specimen banking for future use to include translational medicine studies

    Regulatory Criteria:

    Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

    Voluntary written informed consent must be obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

    As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

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  • open for enrollment

    A Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumors

    Protocol: OSU-16195

    Eligibility:

    Inclusion Criteria:

    For Dose Escalation:

    Subjects with any previously treated advanced (metastatic or refractory) solid

    tumor

    For Cohort Expansion:

    Subjects must have a previously treated advanced solid tumor to be eligible

    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy

    Women of child-bearing potential and men must use an acceptable method of

    contraception during treatment and for 23 weeks after treatment for women and 31

    weeks for men

    Exclusion Criteria:

    Known central nervous system metastases or central nervous system as the only source

    of disease

    Other concomitant malignancies (with some exceptions per protocol)

    Active, known or suspected autoimmune disease

    Uncontrolled or significant cardiovascular disease

    History of active or chronic hepatitis (e.g. Hep B or C)

    Impaired liver or bone marrow function

    Major surgery less than 1 month before start of the study

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors

    Protocol: OSU-16147

    Eligibility:

    Inclusion Criteria:

    Subject is age 18 years or older;

    Subject must have histologically or cytologically confirmed solid tumor;

    Subject must have locally advanced or metastatic solid tumor;

    Subjects who have progressed or have been intolerant to any standard treatment

    regimen or refused standard treatment, or for which adequate standard therapy does

    not exist.

    Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in

    Solid Tumors (RECIST) version 1.1.

    Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0

    or 1;

    If the subject is a woman of child-bearing potential or man who is sexually active

    with woman of child-bearing potential, the subject agrees to use adequate

    contraception from signing of the ICF, for the duration of study participation; and

    for 23 weeks after the last dose of IMP for women or 31 weeks after the last dose of

    IMP for men;

    Subjects who have adequate hematological, renal, hepatic and respiratory functions

    defined.

    The subject is willing to undergo tumor biopsy during the Screening period, or if the

    tumor is inaccessible for biopsy, archived tumor material must be available for

    submission;

    Subjects who voluntarily signed and dated Institutional Review Board approved

    informed consent form in accordance with regulatory and institutional guidelines.

    Exclusion Criteria:

    Female subject who is pregnant or breast-feeding, or any subject expecting to

    conceive or father a child during this study;

    Subjects with uncontrolled and significant inter-current illness.

    Subjects has psychiatric illness/social situations that in the opinion of the

    investigator would limit compliance with study requirements;

    Subjects with known central nervous system (CNS) metastases and/or carcinomatous

    meningitis.

    Subject has received prior therapy for cancer or major surgery within 28 days, or 42

    days for nitrosourea or mitomycin C, prior to Cycle 1 Day 1;

    Subject has received radiotherapy or radiosurgery within 14 days prior to Cycle 1 Day

    1;

    Subject has been previously treated with an anti-PD-1, anti-PD-L1, anti-PD-L2,

    anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically

    targeting T-cell co-stimulation or checkpoint pathways;

    Subject has been previously treated with mogamulizumab;

    Subject has a history of allergy or hypersensitivity to study drug components;

    Subject has received a live, attenuated vaccine within 28 days prior to Cycle 1 Day

    1;

    Subject has a history of organ transplant or allogeneic bone marrow transplant;

    Subject has any unresolved toxicity Grade > 1 from previous anti-cancer therapy

    Subject use of immunosuppressive medication within 14 days before Cycle 1 Day 1.

    Subjects who have known active autoimmune disease or a history of autoimmune disease

    which may affect vital organ function or require immune suppressive treatment

    including systemic corticosteroids;

    Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;

    Subjects who have a history of inflammatory bowel disease, Crohn's disease,

    ulcerative colitis, celiac disease, or Wegener's granulomatosis;

    Subject has primary or acquired immunodeficiency or known history of testing positive

    for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;

    Subject who tests positive for hepatitis B surface antigen (HBVsAg) or hepatitis C

    RNA indicating acute or chronic infection;

    Subject has another active malignancy requiring concurrent intervention;

    Subject who is receiving any other investigational agents;

    Subject has another condition that, in the opinion of the Investigator and/or

    Sponsor, would interfere with evaluation of the IMP or interpretation of subject

    safety or study results;

    Subject has a history of pneumonitis or interstitial lung disease.

    Principal Investigator: Gregory A Otterson, MD

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  • open for enrollment

    LHRH Analogue Therapy with Enzalutamide or Bicalutamide in Treating Patients with Metastatic Hormone Sensitive Prostate Cancer

    Protocol: OSU-13239

    Eligibility:

    Inclusion Criteria:

    Histologically confirmed prostate adenocarcinoma with metastasis either starting or recently started on LHRH analogue therapy; (late induction permitted within 3 months of starting LHRH analogue therapy or antiandrogen); no minimum PSA requirement for patients with measurable disease

    All patients who have not initiated hormone therapy (early induction patients) must have elevated PSA >= 4 ng/ml within 28 days prior to registration; for late induction registrations, PSA must be >= 4 ng/ml prior to start of androgen deprivation therapy; either antiandrogen or LHRH analogue or gonadotropin-releasing hormone (GNRH) antagonist; if patients are on antiandrogen, this will need to be discontinued for at least 7 days prior to registration

    Patients with a history of prior neoadjuvant/adjuvant hormone therapy are eligible provided they have received twenty four or less months of hormone treatment (single or combination treatment, excluding orchiectomy); both therapies (neoadjuvant/adjuvant hormone therapy) must have been discontinued at least 6 months prior to registration; this is intended to exclude patients who might have been rendered indirectly androgen insensitive

    There must be no plans to receive concomitant chemotherapy, biological response modifiers, radiation therapy or hormonal therapy; concomitant radiation therapy is allowed for the palliation of severe pain/neuropathic compression; prior or concomitant use of megestrol acetate for the treatment of hot flashes is allowed

    Patients must have a performance status of 0-2 by Zubrod criteria

    Patients must have recovered from any major infections and/or surgical procedures and, in the opinion of the investigator, not have significant active medical illness precluding protocol treatment or survival

    No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, superficial or in situ cancer of the bladder; for an invasive cancer the patients should be disease free for at least 3 years prior to enrollment on study

    For all patients a bone scan must be performed within 60 days prior to registration for tumor assessment; computed tomography (CT) scans (abdomen and pelvis) and chest x-ray are optional, but must be repeated if used for disease assessment; for late induction registrations, tumor assessment imaging showing metastatic disease must be available prior to start of androgen deprivation therapy

    Willing and able to provide informed consent

    Willingness to swallow pills and no medical condition that would interfere with this

    Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration; patients are also required to use a condom if having sex with a pregnant woman

    Patient should agree to a tumor biopsy prior to protocol enrollment; post therapy biopsy is optional

    Patients who are being treated with a GNRH antagonist should be willing to switch to a LHRH analogue after registration

    Patients must have one of the following a) low volume disease (defined as no visceral metastases and < 4 bone metastases) or b) are not candidates for docetaxel based chemotherapy or c) refused docetaxel chemotherapy

    Exclusion Criteria:

    History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past; also, history of loss of consciousness or transient ischemic attack within 12 months of day 1 visit

    Known or suspected brain metastasis or active leptomeningeal disease

    Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment

    Absolute neutrophil count < 1,000/uL

    Platelet count < 50,000/uL

    Hemoglobin < 8 g/dL

    Total bilirubin > 2.5 times the upper limit of normal

    Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal

    Creatinine > 177 umol/L (2 mg/dL)

    Clinically significant cardiovascular disease including:

    Myocardial infarction within 6 months

    Uncontrolled angina within 3 months

    Congestive heart failure New York Heart Association (NYHA) class 3 of 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless screening echocardiogram or multi-gated acquisition scan performed within 3 months results in a left ventricular ejection fraction that is >= 45%

    History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)

    History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place

    Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mmHg) at the screening visit

    Bradycardia as indicated by a heart rate of < 50 beats per minute on the screening electrocardiogram (ECG)

    Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg

    Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months)

    Treatment with concurrent 5-alpha reductase inhibitors (finasteride, dutasteride), estrogens, and/or cyproterone

    Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH-analogue therapy) or other agents with anti-tumor activity within 4 weeks of enrollment (day 1 visit)

    History of prostate cancer progression of ketoconazole

    Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-683, TAK-448) or agents that block the androgen receptor (e.g., ARN-509)

    Previous enzalutamide therapy

    Use of an investigational agent within 2 weeks of enrollment (day 1 visit)

    Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of replacement steroids or > equivalent of 10 mg of prednisone per day within 4 weeks of enrollment (day 1 visit)

    Any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which place the patient at undue risk, or complicates the interpretation of safety data

    Prior chemotherapy for metastatic disease

    >= 30 days of antiandrogen therapy monotherapy without androgen deprivation therapy

    Life expectancy of 6 months or less

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  • open for enrollment

    Quality of Life and Supportive Care Preferences following Radiation Therapy in Prostate Cancer Survivors

    Protocol: OSU-15049

    Eligibility:

    Inclusion Criteria:

    English speaking

    Diagnosis of prostate cancer

    Treatment with primary radiation (brachytherapy or external beam therapy), radiation + androgen deprivation therapy (ADT) or salvage prostatectomy

    Body mass index (BMI) (26 - 40 kg/m^2)

    Treating oncologist consent

    Ambulatory or able to engage in walking for at least 45 minutes per intervention visit

    Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week

    Exclusion Criteria:

    Poor diagnosis or other cancer

    Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension

    Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician

    Non-ambulatory

    Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit

    Major mental illness (e.g., schizophrenia, major depressive disorder)

    Unwilling to give consent

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