Prostate Cancer

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The Role of Androgen Deprivation Therapy In Cardiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC1) & A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICAL PC2)


Condition: Prostate Cancer, Cardiovascular Disease

Intervention:

  • Behavioral: Nutrition
  • Behavioral: Exercise
  • Behavioral: Smoking cessation
  • Drug: Antiplatelet agent, such as Aspirin, or other low-dose antiplatelet agent
  • Drug: Statin, such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
  • Drug: ACE inhibitor

Purpose: RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03127631

Sponsor: McMaster University

Primary Outcome Measures:

  • Measure: Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
  • Time Frame: 3-5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - CV Death
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Stroke
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Heart Failure
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism
  • Time Frame: 3-5 years
  • Safety Issue:

Estimated Enrollment: 6000

Study Start Date: October 2015

Eligibility:

  • Age: minimum 45 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. A man with a diagnosis of prostate cancer that is either:
  • new (i.e. the diagnosis was made within 1 year of the baseline visit) or
  • treated with Androgen Deprivation Therapy for the first time within 1 month prior to the baseline visit, or
  • to be treated with Androgen Deprivation Therapy for the first time within 1 month after the baseline visit

Exclusion Criteria:

  • 1. Unwilling to provide consent, or 2. Are <45 years of age 3. Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
  • see a cardiologist every year, or
  • are undertaking all of the following:
  • aspirin use, and
  • statin use, and
  • ACE-I use, and
  • exercise 4 or more times per week

Contact:

  • Kayla Pohl, BA, CCRP
  • 905-527-4322 Ext. 40694

Locations:

  • William Osler Health System
  • Brampton Ontario L6R 3J7 Canada
  • St. Joseph's Healthcare
  • Hamilton Ontario L8N4A6 Canada
  • Juravinski Cancer Centre
  • Hamilton Ontario L8V1C3 Canada
  • Queen's University
  • Kingston Ontario K7L 3J7 Canada
  • London Health Sciences Centre
  • London Ontario N6A 5W9 Canada
  • Ottawa Hospital Research Institute
  • Ottawa Ontario K1H 8L6 Canada
  • Sunnybrook Health Sciences Centre
  • Toronto Ontario M4N 3M5 Canada
  • University Hospital of Montreal
  • Montreal Quebec H2X 0A9 Canada
  • Jewish General Hospital
  • Montreal Quebec H3T 1E2 Canada
  • Laval University
  • Quebec City Quebec G1V 0A6 Canada

View trial on ClinicalTrials.gov


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Molecular Mechanisms Underlying Prostate Cancer Disparities.


Condition: Prostate Cancer

Intervention:

  • Device: Biopsy or prostatectomy

Purpose: The purpose of this study is to further elucidate the molecular mechanisms underlying prostate cancer disparities. In previous work the investigators have identified a set of differentially deregulated genes in African American versus Caucasian American prostate cancer. Based on these findings, they hypothesize that they will be able to validate these targets, originally identified in the previous work conducted at The George Washington University Medical Center, in an independent Duke University Medical Center cohort of prostate cancer specimens. In addition, the investigators hypothesize that they will be able to discover novel targets in the Duke University Medical Center cohort of prostate cancer specimens because of regional differences.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02229565

Sponsor: Duke University

Primary Outcome Measures:

  • Measure: Proportion of high and low expression of identified gene targets in Caucasian and African American specimens
  • Time Frame: up to 2 years
  • Safety Issue:

Estimated Enrollment: 198

Study Start Date: November 2014

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Suspected malignancy of prostate cancer
  • Self-reported race of African American or Caucasian American
  • Age >/= 18 years
  • Able to read, understand and sign an informed consent document

Exclusion Criteria:

  • Collected tumor tissue is inadequate for DNA and RNA analysis and/or is not positive for adenocarcinoma of the prostate.
  • Patients with prior systemic therapy will not be eligible for the study, i.e. radiation or chemo or immunotherapy.

Contact:

  • Monika Anand
  • 919.681.8838

Location:

  • Duke University Medical Center
  • Durham North Carolina 27710 United States

View trial on ClinicalTrials.gov


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Defining the Relevant Immune Checkpoints Expressed on Metastatic Prostate Cancer Circulating Tumor Cells


Condition: Prostate Cancer

Intervention:

  • Device: CTC biomarker expression prevalence

Purpose: This pilot study will explore the prevalence of expression of four immune checkpoint biomarkers on circulating tumor cells (CTCs) from men with metastatic prostate cancer that are captured by EpCAM via the CellSearch method, and specifically defined as co expressing DAPI and cytokeratin, and lacking CD45 expression.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02456571

Sponsor: Duke University

Primary Outcome Measures:

  • Measure: Change in expression of four immune checkpoint biomarkers (PD-L1, PD-L2, B7-H3, and CTLA-4) on circulating tumor cells (CTCs).
  • Time Frame: Baseline to Week 12
  • Safety Issue:
  • Measure: Change in expression of four immune checkpoint biomarkers (PD-L1, PD-L2, B7-H3, and CTLA-4) on circulating tumor cells (CTCs).
  • Time Frame: Baseline to Progression or week 12 whichever occurs first
  • Safety Issue:

Estimated Enrollment: 40

Study Start Date: November 2016

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Exclusion Criteria:

  1. History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
  2. Treatment with an anthracycline (including mitoxantrone) within 1 week of CTC collection, as anthracyclines cause auto-fluorescence of cells.

Contact:

  • Monika Anand, PhD
  • (919)681-8838

Location:

  • Duke University Medical Center
  • Durham North Carolina 27710 United States

View trial on ClinicalTrials.gov


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A Phase Ib Study of Intravenous Copper Loading With Oral Disulfiram in Metastatic, Castration Resistant Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Drug: Copper
  • Drug: Disulfiram
  • Drug: Copper gluconate

Purpose: The purpose of this study is to determine the safety and optimal dosing of intravenous copper chloride and disulfiram in men with metastatic castrate-resistant prostate cancer (CRPC). Eligible men will have neuroendocrine prostate cancer (NEPC), adenocarcinoma CRPC with non-liver/peritoneal metastases (lymph nodes, bone, or lung) or adenocarcinoma CRPC with liver and/or peritoneal metastases. Subjects will receive three doses of intravenous copper chloride and take disulfiram and oral copper gluconate until disease progression (up to two years). Subjects will also undergo a PET scan with radioactive copper 64 to measure the levels of copper in their tumor. The central hypotheses of this project are that (a) copper chloride and disulfiram are safe to give together and that (b) the combination of disulfiram with copper will have efficacy for both mCRPC and NEPC.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02963051

Sponsor: Daniel George, MD

Primary Outcome Measures:

  • Measure: Number of adverse events
  • Time Frame: Up to 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Median radiographic progression free survival (PFS)
  • Time Frame: Every 12 weeks, up to 2 years
  • Safety Issue:
  • Measure: Amount of 64-Copper uptake by the tumor
  • Time Frame: Baseline
  • Safety Issue:
  • Measure: Change in PSA
  • Time Frame: Every 4 weeks, up to 2 years
  • Safety Issue:
  • Measure: Time to PSA nadir
  • Time Frame: Every 4 weeks, up to 2 years
  • Safety Issue:
  • Measure: Time to PSA progression
  • Time Frame: Every 4 weeks, up to 2 years
  • Safety Issue:

Estimated Enrollment: 36

Study Start Date: July 11, 2017

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Age ≥ 18 years 2. Karnofsky performance status ≥ 70 3. Life expectancy of ≥ 12 weeks as determined by treating investigator 4. Adequate laboratory parameters
  • Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 80 x 109/L, Hb>9 g/dL
  • AST/SGOT and ALT/SGPT ≤ 2.5 x Institutional Upper Limit of Normal (ULN)
  • Serum bilirubin ≤ 1.5 x Institutional ULN
  • Serum creatinine ≤ 1.5 x Institutional ULN or 24-hour clearance ≥ 50 mL/min 5. Histologically confirmed diagnosis of prostate cancer. Histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are included.If neuroendocrine prostate cancer is not biopsy proven, clinical evidence of neuroendocrine prostate cancer is acceptable for stratification into group A. 6. Radiographic evidence of metastatic disease. 7. Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. OR Screening serum testosterone must be <50 ng/dl. 8. Evidence of disease progression on ADT as evidenced by one of the following:
  • 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR
  • CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to PCWG3 criteria or RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies, OR
  • Absolute rise in PSA of 2.0ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level 9. A minimum of 2 weeks elapsed off of antiandrogen therapy prior to registration (i.e. flutamide, nilutamide, and bicalutamide) without evidence of an anti-androgen withdrawal response. An anti-androgen withdrawal response is a PSA level at 2 weeks (or more) off of anti-androgen equal or higher than PSA level when anti-androgen therapy stopped. 10. For subjects in Groups B or C, previous use of at least one androgen pathway inhibitor (either abiraterone acetate or enzalutamide) for metastatic CRPC 11. For subjects in Group A with NEPC, previous use of at least one platinum-containing chemotherapy regimen. 12. A minimum of 4 weeks off of enzalutamide or abiraterone if applicable. 13. A minimum of 4 weeks from prior chemotherapy, including but not limited to, docetaxel, cabazitaxel, mitoxantrone, carboplatinum, cisplatin, or estramustine; if applicable. 14. A minimum of 4 weeks from any major surgery prior to registration. 15. Ability to swallow, retain, and absorb oral medication. 16. Ability to understand and the willingness to sign a written informed consent document. 17. Willingness to abstain from alcohol or any alcohol-containing fluids for the duration of the study.

Exclusion Criteria:

  1. Subjects who meet any of the following criteria will be excluded from the study:
  2. Symptomatic subjects who accept treatment with approved palliative or life-prolonging therapies, including docetaxel and cabazitaxel chemotherapy. (Note: subjects who refuse chemotherapy or are not symptomatic or in immediate need for standard systemic therapies may be included.)
  3. Known history of Wilson's disease or a copper deficiency.
  4. Uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP > 95 mmHg) or other medical condition that could jeopardize the assessment of toxicity on study.
  5. Active or symptomatic viral hepatitis or chronic liver disease.
  6. Known history of Hepatitis B Virus (HBV) or Hepatitis C (HCV) infection.
  7. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline.
  8. Symptomatic atrial fibrillation or other cardiac arrhythmia for which the therapy is not stable or requiring changes in therapy within 1 month of treatment initiation. Atrial fibrillation or other cardiac arrhythmia which is clinically stable on stable therapy is allowed.
  9. Corrected QT interval calculated by the Bazett formula (QTcB) >480 msec.
  10. Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of death within 24 months.
  11. Administration of an investigational therapeutic within 30 days of Cycle 1, Day
  12. Any condition which, in the opinion of the investigator, would preclude participation in this trial.

Contact:

  • Julia Rasmussen, MS, RN, BSN
  • 919-681-1030

Location:

  • Duke University Medical Center
  • Durham North Carolina 27710 United States

View trial on ClinicalTrials.gov


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A Pre-Operative Study to Assess the Effects of Apalutamide Plus LHRH Agonist or Apalutamide Plus Abiraterone Acetate Plus LHRH Agonist for Six Months for Prostate Cancer Patients at High Risk for Recurrence


Condition: Diseases of Male Genital Organs, Prostate Cancer

Intervention:

  • Drug: LHRH Agonist
  • Drug: Apalutamide
  • Drug: Abiraterone Acetate
  • Drug: Prednisone

Purpose: The goal of this clinical research study is to learn if adding abiraterone acetate and standard of care prednisone to the combination of apalutamide and a standard type of drug called an LHRH agonist can help to control prostate cancer when given before surgery. The safety of these drug combinations will also be studied. This is an investigational study. Apalutamide is not FDA approved or commercially available. It is currently being used for research purposes only. The combination of abiraterone acetate, LHRH agonists, and prednisone is FDA approved and commercially available for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Both drug combinations being used in this study are considered investigational. Up to 66 participants will be enrolled in this study. All will take part at MD Anderson.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03279250

Sponsor: M.D. Anderson Cancer Center

Primary Outcome Measures:

  • Measure: Rate of Pathologic Stage ≤ ypT2 N0 at Prostatectomy
  • Time Frame: At surgical procedure
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Tumor Epithelium Volume at Prostatectomy
  • Time Frame: After 6, 28 day cycles
  • Safety Issue:
  • Measure: Rate of Positive Surgical Margins at Prostatectomy
  • Time Frame: After 6, 28 day cycles
  • Safety Issue:
  • Measure: Time to PSA Recurrence
  • Time Frame: 4 weeks post prostatectomy
  • Safety Issue:
  • Measure: Adverse Events of Apalutamide With and Without Abiraterone Acetate and Low Dose Prednisone
  • Time Frame: Monthly up to 4 weeks after prostatectomy
  • Safety Issue:

Estimated Enrollment: 66

Study Start Date: October 13, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate with no histological variants (such as small cell, sarcomatoid, pure ductal cancer, transitional cell carcinoma).
  2. Patients may have received one prior depot injection of LHRH agonist or LHRH antagonist (degarelix) within 30 days prior to study entry. Patients who have received any other prior hormonal therapy or any chemotherapy for prostate cancer will be excluded. (Patients who have discontinued finasteride or dutasteride or testosterone supplement for at least 2 weeks will be allowed to enroll).
  3. Be willing/able to adhere to the prohibitions and restrictions specified in this protocol.
  4. Have signed an informed consent document indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.
  5. Written Authorization for Use and Release of Health and Research Study Information has been obtained.
  6. Age >/=18 years. Because no dosing or adverse event data are currently available on the use of Abiraterone in combination with apalutamide (in patients <18 years of age, children are excluded from this study.
  7. Pathology review at MD Anderson (Note: if patient's prostate biopsy was not read at MD Anderson, it must be reviewed at the study site to confirm eligibility).
  8. Prostate Biopsy. If previous biopsy has been performed within 3 months of screening, second biopsy procedure will not be required, if archival biopsies and at least one formalin fixed paraffin embedded biopsy tissue block containing tumor is available.
  9. The following tumor stage and Gleason scores: a) Clinical >/= stage T1c/T2 tumor with Gleason score >/=8 b) Clinical stage >/=T2b tumor with Gleason score >/=7 and PSA >10 ng/ml
  10. Serum testosterone >150 ng/dL. For patients treated up to 1 month of LHRH agonist, a testosterone measurement prior to the LHRH treatment will be used to determine eligibility, and must have been > 150 ng/dL. If no testosterone level is available from before LHRHa injection up to 30 days prior to study entry, the patient will be ineligible.
  11. Patient is suitable for prostatectomy.
  12. No evidence of metastatic disease as determined by imaging procedures.
  13. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
  14. Hemoglobin >/= 9.0 g/dL independent of transfusion; b) Platelet count >/=100,000/µL. c) Patients should have adequate bone marrow function defined as an absolute peripheral neutrophil count (ANC) >1,000; d) Creatinine clearance >/= 50 mL/min; e) Serum potassium >/= 3.5 mmol/L; f) Serum bilirubin /= 3 g/dl
  15. Able to swallow the study drug whole as a tablet.
  16. Patients must have normal coagulation profile and no history of substantial non- iatrogenic bleeding diathesis.
  17. Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
  18. Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken.
  19. Life expectancy of greater than 12 months.

Exclusion Criteria:

  1. Patients who have had any prior chemotherapy or radiotherapy for prostate cancer.
  2. Patients who have had >1 LHRH agonist or antagonist depot injection or received depot injection > 30 days before study entry.
  3. Patients may not be receiving any other investigational agents.
  4. Patients may not be receiving the concomitant administration of any systemic therapy, biologic therapy, or other agents with anti-tumor activity against prostate cancer while the patients are on study.
  5. Patients with known metastatic prostate cancer.
  6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide acetate, abiraterone acetate, prednisone or apalutamide or other agents used in the study.
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  8. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Apalutamide and Abiraterone. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  9. Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. If a strong CYP3A4 inducer must be co-administered, increase the abiraterone acetate dosing frequency.
  10. Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate.
  11. Patients receiving medications known to lower the seizure threshold are ineligible unless discontinued or substituted at least 4 weeks prior to study entry. These include: 1) Aminophylline/theophylline; 2) Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone); 3) Bupropion; 4) Lithium; 5) Pethidine; 6) Phenothiazine antipsychotics (e.g., prochlorperazine (compazine), chlorpromazine, mesoridazine, thioridazine); 7) Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
  12. Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 170 or diastolic pressures above 110 despite anti-hypertensive therapy. Note that this is NOT a criterion related to particular BP results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (for example doctor's visit related stress i.e. "white coat syndrome".
  13. Requirement for corticosteroids greater than the equivalent of 10 mg of prednisone daily for more than 2 weeks.
  14. Poorly controlled diabetes defined by Hemoglobin A1C > 9.0 at screening
  15. Active or symptomatic viral hepatitis or chronic liver disease.
  16. Known history of pituitary or adrenal dysfunction.
  17. Other malignancy, except non-melanoma skin cancer, that is active or has a >/= 30% probability of recurrence within 12 months.
  18. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.
  19. Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or LHRH agonists/antagonists (*Note: LHRH allowed if begun within 1 month of Day 1).
  20. Prior systemic treatment with an azole drug within four weeks of Cycle 1 Day
  21. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of Cycle 1 Day
  22. Allergies, hypersensitivity, or intolerance to prednisone, LHRH analog or excipients of prednisone LHRH analog, abiraterone acetate and apalutamide.
  23. Previous use of abiraterone acetate or other investigational CYP17 inhibitor (e.g., TAK-700).
  24. Previous investigational antiandrogens (e.g., apalutamide, enzalutamide, BMS-641988).
  25. Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study.
  26. Patients unable to tolerate transrectal ultrasound.
  27. Anti-androgens (steroidal or non-steroidal) such as cyproterone acetate, flutamide, nilutamide, bicalutamide, etc. other than assigned study drug unless given for
  28. Estrogens, progestational agents such as megestrol, medroxyprogesterone, DES, cyproterone, spironolactone > 50 mg/kg, etc. unless discontinued at least two weeks prior to randomization.
  29. Androgens such as testosterone, dehydroepiandrosterone [DHEA], etc. unless discontinued at least two weeks prior to randomization.
  30. Herbal products that may decrease PSA levels (e.g., saw palmetto) unless discontinued two weeks prior to randomization.
  31. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated.
  32. Severe hepatic impairment (Child-Pugh Class C).
  33. History of significant bleeding disorder unrelated to cancer, including: 1) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease); 2) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) of screening visit; 3) History of GI bleeding within 3 months of screening visit requiring >/=2 units packed red blood cells.
  34. Clinically significant cardiovascular disease including: 1) Myocardial infarction within 6 months of Screening visit; 2) Uncontrolled angina within 3 months of Screening visit; 3) Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within three months of the Screening visit results in a left ventricular ejection fraction that is >/= 50%.
  35. continued: 4) History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes). 5) Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the screening Electrocardiogram (ECG) > 470 msec. 6) History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place. 7) Hypotension (systolic blood pressure < 86 mmHg or bradycardia with a heart rate of <50 beats per minute on the Screening ECG., unless pharmaceutically induced and thus reversible (i.e. beta blockers).

Contact:

  • Eleni Efstathiou, MD, PHD
  • 713-792-2830

Location:

  • University of Texas MD Anderson Cancer Center
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels


Condition: Prostate Cancer

Intervention:

  • Drug: Apalutamide
  • Drug: Abiraterone
  • Drug: ADT
  • Drug: Prednisone

Purpose: Evaluation of the activity, safety and patients reported outcome of ADT plus abiraterone, abiraterone plus APALUTAMIDE (a second-generation antiandrogen) or APALUTAMIDE alone in hormone naïve locally advanced or metastatic prostate cancer which ADT was indicated.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02867020

Sponsor: Latin American Cooperative Oncology Group

Primary Outcome Measures:

  • Measure: Number of patients that achieves an undetectable PSA level, defined as ≤ 0.2 ng/mL
  • Time Frame: Week 25
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: PSA progression rate
  • Time Frame: Week 25
  • Safety Issue:
  • Measure: Comparison of PSA progression rate
  • Time Frame: Week 25
  • Safety Issue:
  • Measure: PSA response of 50 and 80%
  • Time Frame: Week 25
  • Safety Issue:
  • Measure: Comparison of PSA response of 50 and 80%
  • Time Frame: Week 25
  • Safety Issue:
  • Measure: Maximum PSA declines
  • Time Frame: Baseline up to week 25 to 52
  • Safety Issue:
  • Measure: Overall PSA change
  • Time Frame: Baseline up to week 25 to 52
  • Safety Issue:
  • Measure: Hormonal levels during treatment
  • Time Frame: Baseline up to week 25
  • Safety Issue:
  • Measure: Comparison of hormonal levels during treatment
  • Time Frame: Baseline up to week 25
  • Safety Issue:
  • Measure: Evaluation of bone mineral density according to RECIST 1.1
  • Time Frame: Week 25
  • Safety Issue:
  • Measure: Comparison of bone mineral density according to RECIST 1.1 between three experimental groups
  • Time Frame: Week 25
  • Safety Issue:
  • Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  • Time Frame: Baseline to 2 years of follow-up
  • Safety Issue:
  • Measure: Number of participants with pain progression assessed by BPI-SF of three experimental arms
  • Time Frame: Baseline up to week 25
  • Safety Issue:
  • Measure: Number of participants in opioid use during treatment among three experimental arms
  • Time Frame: Baseline up to week 25
  • Safety Issue:
  • Measure: Comparison of pain progression assessed by opioid use
  • Time Frame: Baseline up to week 25
  • Safety Issue:
  • Measure: Comparison of pain progression assessed by BPI-SF questionnaire
  • Time Frame: Baseline up to week 25
  • Safety Issue:
  • Measure: Quality of life assessed by FACT-P questionnaire
  • Time Frame: Baseline up to week 25
  • Safety Issue:
  • Measure: Comparison of quality of life assessed by FACT-P questionnaire
  • Time Frame: Baseline up to week 25
  • Safety Issue:
  • Measure: Radiographic progression-free survival (rPFS)
  • Time Frame: Week 25
  • Safety Issue:

Estimated Enrollment: 126

Study Start Date: October 11, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Histologically confirmed prostate adenocarcinoma; 2. Hormone naïve patients with indication to ADT in the following settings:
  • Advanced loco-regional disease not amenable to curative local therapy (surgery or radiotherapy): T category T3/4 or node positive
  • Biochemical relapse after primary treatment (surgery or radiotherapy): patients in whom primary therapy is not appropriate or feasible with Previously treated with radical surgery and/or radiotherapy, now relapsing with at least one of the criteria: PSA >= 4 ng/ml and rising with doubling time less than 10 months. or PSA >= 20 ng/ml or N+ or M+
  • Newly diagnosed metastatic disease: Tany Nany M+ 3. Patient is asymptomatic or moderately symptomatic regarding bone symptoms, i.e., no need for palliative radiation or radionuclide therapy; 4. Non-castration level of testosterone > 230ng/dL (> 8 nmol/L); 5. Baseline level of prostatespecific antigen (PSA) > 2ng/dL; 6. ECOG performance status of 0 to 2; 7. Adequate hematologic, hepatic and renal function: 1. hemoglobin > 10 g/dL, neutrophils > 1.5×109 / L, platelets> 100×109 / L; 2. total bilirubin < 1.5x upper limit of normal (ULN); alanine (ALT) and aspartate (AST) aminotransferase < 2.5 x ULN; 3. serum creatinine < 1.5x ULN; potassium > 3.5 mM; 8. No previous cancer (except treated basal-cell skin cancer); 9. Written informed consent obtained prior to any study procedure; 10. Men age 18 years and older; 11. Agrees to use a condom and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant.

Exclusion Criteria:

  1. Prostate adenocarcinoma with neuroendocrine differentiation or small cell histology;
  2. Biochemical recurrence without evidence of clinical or radiological disease;
  3. Use of hormonal therapy or chemotherapy prior to randomization. Exception is courses of hormone therapy for localised disease must have been completed at least 12 months previously. It can have been given as adjuvant or neoadjuvant therapy.
  4. Prior radiation therapy for a primary tumour within the 3 months before enrollment or for the treatment of metastases;
  5. Known or suspected brain or skull metastases or leptomeningeal metastatic disease;
  6. Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study;
  7. Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 28 days of Cycle 1 Day 1 or currently enrolled in an investigational study;
  8. Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction;
  9. Current or prior treatment with anti-epileptic medications for the treatment of seizures;
  10. Impaired cardiac function, including any of the following:
  11. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥95 mmHg);
  12. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events or history of cardiac failure in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease;
  13. Existing atrial fibrillation with or without pharmacotherapy. Other cardiac arrhythmia requiring pharmacotherapy;
  14. History of seizure or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect);
  15. Specific underlying conditions for oral agents. For example: impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of abiraterone or APALUTAMIDE (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  16. General excluded medications (e.g., relevant to cytochrome P450 interactions)
  17. Use of prescription drugs within 14 days prior to dosing or over-the-counter (OTC) medication within 7 days prior to dosing;
  18. Consumption of grapefruit product or St John's wort within 7 days prior to dosing;
  19. G-CSF, GM-CSF, erythropoietin, etc;
  20. Coumadin;
  21. Drugs which may cause QT prolongation;
  22. Known sensitivity to drugs or metabolites from similar classes;
  23. Known or suspected contraindications or hypersensitivity to APALUTAMIDE, bicalutamide or GnRH agonists or any of the components of the formulations;
  24. Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subject's participation in this study.

Contact:

  • Laura Voelcker
  • 55 51 3384 5334

Locations:

  • Clínica AMO
  • Salvador Bahia Brazil
  • CRIO
  • Fortaleza Ceará Brazil
  • CPO - Pucrs
  • Porto Alegre Rio Grande do Sul Brazil
  • Oncologia Rede D'Or S.A.
  • Rio de Janeiro RJ 22281 100 Brazil
  • Hospital de Câncer de Barretos
  • Barretos São Paulo Brazil
  • Centro de Pesquisa Clínica em Hematologia e Oncologia - CEPHO
  • Santo André São Paulo Brazil
  • Grupo COI
  • Rio de Janeiro Brazil
  • Beneficiencia Portuguesa de São Paulo/Hospital São José
  • São Paulo Brazil
  • Hospital Israelita Albert Einstein
  • São Paulo Brazil
  • ICESP
  • São Paulo Brazil

View trial on ClinicalTrials.gov


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Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer


Condition: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention:

  • Radiation: stereotactic radiosurgery
  • Device: magnetic resonance imaging
  • Other: quality-of-life assessment
  • Procedure: Serum Prostate Antigen Test
  • Procedure: Digital Rectal Exam
  • Behavioral: Expanded Prostate Cancer Index Composite

Purpose: This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02163317

Sponsor: Case Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: Number of patients with change in EPIC bowel domain score that was worse than 5 points
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Number of patients with change in EPIC urinary domain score that was worse than 2 points
  • Time Frame: Up to 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: PSA response
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Number of acute gastrointestinal (GI) grade 3+ acute adverse events, evaluated by the Cancer Therapy Evaluation Program (CTEP) active version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
  • Time Frame: Up to 30 days after the completion of radiation therapy
  • Safety Issue:
  • Measure: Number of acute genitourinary (GU) grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Number of late GI grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Number of late GU grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Number of patients with Disease-free survival
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Time to local progression
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Time to distant failure
  • Time Frame: Up to 2 years
  • Safety Issue:

Estimated Enrollment: 12

Study Start Date: February 3, 2016

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patients must have a histologically confirmed diagnosis of adenocarcinoma of the prostate
  • Patient must have a history/physical examination with digital rectal examination of the prostate within 90 days prior to screening
  • Eastern Cooperative Oncology Group (ECOG) performance status must be level 0 or 1 within 60 days prior to registration
  • Patient must have a histological evaluation of the prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7(3+4)
  • Serum creatinine ≤ 1.5 times upper limit of institutional normal (normal: ≤ 1.17 mL/min/1.73 m^2)
  • Clinical stage a ≤ T1-T2a (American Joint Committee on Cancer [AJCC] 7th edition)
  • Prostate specific antigen (PSA) ≤ 10 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document
  • Patient willing and able to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy)
  • Patients must be able to undergo an MRI with contrast
  • Bone scan completed within 90 days

Exclusion Criteria:

  • Evidence of distant metastases
  • Regional lymph node involvement
  • Previous radical surgery (prostatectomy), cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)
  • Use of finasteride within 30 days prior to registration; PSA should not be obtained prior to 30 days after stopping finasteride
  • Use of dutasteride within 90 days prior to registration; PSA should not be obtained prior to 90 days after stopping dutasteride
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer
  • 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; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control (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 unable to undergo an MRI with contrast

Contact:

  • Bryan Traughber, MD
  • 216-844-3061

Location:

  • Case Comprehensive Cancer Center
  • Cleveland Ohio 44106-5065 United States

View trial on ClinicalTrials.gov


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