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Trial record 92 of 103 for:    "Kennedy disease"

Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases

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ClinicalTrials.gov Identifier: NCT02582749
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
Hoosier Cancer Research Network
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Ajjai Alva, MD, Hoosier Cancer Research Network

Brief Summary:
Newly diagnosed metastatic prostate cancer subjects with bone metastases will be accrued to this stratified randomized 2-arm Phase II trial. Subjects will be randomized 1:2 to ADT or ADT with Radium-223 dichloride respectively.

Condition or disease Intervention/treatment Phase
Prostate Cancer Bone Metastases Prostate Neoplasms Drug: LHRH agonist/antagonist Drug: Bicalutamide Radiation: Radium-223 dichloride Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Androgen Deprivation Therapy With or Without Radium-223 Dichloride in Patients With Newly Diagnosed Metastatic Prostate Cancer With Bone Metastases: Hoosier Cancer Research Network GU13-170
Actual Study Start Date : April 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Active Comparator: Control Arm A
All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days.
Drug: LHRH agonist/antagonist
Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.
Other Name: Per treating physician

Drug: Bicalutamide
Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.
Other Name: Casodex

Experimental: Experimental Arm B
All subjects will receive LHRH agonist/antagonist per dosage and route of administration specified by the treating physician. Bicalutamide, 50mg, PO will be administered daily. Cycles will be 28 days. Radium-223 dichloride, 50 kBq/kg body weight, will be administered as a bolus intravenous (IV) injection at intervals of every 28 days for up to 6 cycles.
Drug: LHRH agonist/antagonist
Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.
Other Name: Per treating physician

Drug: Bicalutamide
Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.
Other Name: Casodex

Radiation: Radium-223 dichloride
Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections




Primary Outcome Measures :
  1. Radiological Progression-Free Survival (rPFS) [ Time Frame: From date of randomization to disease progression or death from any cause, up to a maximum of 24 months. ]
    rPFS assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) to compare outcomes of subjects on experimental arm vs control arm


Secondary Outcome Measures :
  1. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) [ Time Frame: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months ]
    The intensity of AEs for subjects on both arms graded according to CTCAE v4.0 on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death)

  2. Time to First Skeletal-Related Event (SRE) [ Time Frame: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months ]
    SRE of subjects on both arms assessed by bone scan or axial imaging

  3. Secondary Neoplasms [ Time Frame: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months ]
    Secondary neoplasms of subjects on both arms assessed by bone scan or axial imaging

  4. PSA Complete Response Rates [ Time Frame: From date of first dose of androgen deprivation therapy (ADT) until completion of 7 cycles (28 weeks) ]
    Subjects on both arms with PSA ≤ 0.2 ng/mL after 7 months of androgen deprivation therapy

  5. PSA Partial Response Rates [ Time Frame: From date of first dose of ADT until completion of 7 cycles (28 weeks) ]
    Subjects on both arms with PSA between 0.2 and ≤ 4 ng/mL after 7 months of androgen deprivation therapy.

  6. Median Time to Castration Resistance [ Time Frame: From date of ADT (first LHRH agonist/antagonist/surgical castration) to date of PSA and/or radiographic progression, assessed for a maximum of 24 months ]
    Castration resistance for subjects on both arms determined by first PSA level increase and/or radiographic progression by first imaging assessment showing progression

  7. 2-Year PSA Progression Free Survival (PFS) [ Time Frame: From date of randomization to first occurrence of PSA progression, symptomatic deterioration, or death due to any cause, assessed up to 24 months ]
    PSA PFS for subjects on both arms defined as first PSA level increase

  8. 2-Year Overall Survival (OS) [ Time Frame: From date of randomization to death from any cause, assessed up to 24 months ]
    OS for subjects on both arms

  9. 12-Week Alkaline Phosphatase (ALP) Normalization [ Time Frame: From date of randomization until completion of 12 weeks of therapy ]
    ALP normalization for subjects with abnormal ALP at randomization

  10. Time to ALP Progression [ Time Frame: From date of randomization until date of ALP progression, assessed up to 24 months ]
    ALP progression of 25% or greater from baseline/nadir for subjects on both arms

  11. Change in Pain Over Time [ Time Frame: From baseline until 30 days after the last treatment, assessed for a maximum of 24 months ]
    Subjects on both arms self-reported evaluation of worst pain item, as well as the subscale scores for pain severity and pain interference as determined by subject responses on the BPI-SF questionnaire.

  12. Analgesic Use by WHO Ladder Score [ Time Frame: From baseline until 30 days after the last treatment, assessed for a maximum of 24 months ]
    Analgesic use scores for subjects on both arms will be assigned by the treating physician based on the subject's daily analgesic use on average. A single numeric score (0, 1, 2 or 3) will be assigned based on the 3-step WHO pain ladder.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects or their legally authorized representative must be informed of the investigational nature of the study and provide written informed consent and HIPAA authorization for release of personal health information before performance of any study related procedure not part of routine medical care. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Men ≥ 18 years of age at the time of informed consent.
  • Histological or cytological evidence of prostate adenocarcinoma.
  • All subjects must have radiologic or pathologic evidence of ≥ 2 skeletal lesions with or without pain at baseline on bone scan or axial imaging or 1 skeletal lesion and bone pain within 28 days prior to the registration.
  • All subjects must have a radiographic assessment (chest or abdominal/pelvic CT or MRI) within 28 days prior to registration but do not need to have measurable disease.
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2 within 28 days prior to registration. ECOG Performance Status of 3 will only be allowed if judged by the treating investigator as attributable exclusively to bone pain.
  • Subjects must fall into one of the two populations below:
  • EARLY INDUCTION GROUP: Subjects who have started androgen deprivation therapy (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with or without an anti-androgen agent) a maximum of 28 days before registration and who otherwise meet all the eligibility criteria.
  • LATE INDUCTION GROUP: Subjects who have NOT started any androgen deprivation therapy (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with or without an antiandrogen agent).
  • Anti-androgen receptor antagonist therapy must be bicalutamide. Subjects already started on other anti-androgens must be willing to switch over to bicalutamide.
  • Any prior androgen-deprivation therapy or finasteride as neoadjuvant or adjuvant therapy or for biochemical recurrence must have been discontinued at least 6 months prior to registration.
  • Prior surgical treatment for prostate cancer is allowed but must have been completed at least 14 days prior to registration and any toxicity from such therapy must have recovered to ≤ grade 1 per CTCAE version 4 criteria by the time of registration.
  • All subjects, including those who are surgically sterilized, must be willing to use an effective method of contraception (barrier method of birth control or abstinence) from the time informed consent is signed until 6 months after completion of protocol therapy.
  • Subjects must consent to bank whole blood, serum, plasma for future unspecified studies.

Exclusion Criteria:

  • Prior cytotoxic chemotherapy for metastatic prostate cancer. Prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed but must have been completed at least 6 months prior to registration. No cytotoxic chemotherapy is allowed during protocol specified therapy.
  • Prior concomitant therapy with ketoconazole, aminoglutethimide or abiraterone acetate or enzalutamide (MDV3100) or intent to treat with the above. Concurrent megestrol for hot flashes is allowed.
  • Prior or ongoing bisphosphonate (e.g,. zoledronic acid) or RANKL inhibitor (e.g. denosumab) use is NOT allowed except when used solely for osteoporosis and strictly per guidelines for that indication. Bisphosphonate or RANKL inhibitor cannot be initiated for any indication during protocol specified therapy without consent of the sponsor-investigator of the study.
  • Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188.
  • Diagnosis of aplastic anemia, pure red cell aplasia, myelodysplasia or any of the other bone marrow failure states.
  • Any neuroendocrine differentiation including small cell carcinoma on histology or cytology.
  • No prior malignancy except for non-melanomatous skin cancer or non-muscle invasive bladder cancer or adequately treated Stage I or II cancer (adequacy at discretion of treating investigator) from which the subject is currently in complete remission, or any other cancer from which the subject has been disease-free for at least 3 years.
  • History of or active CNS metastasis (brain, leptomeningeal or cord compression). Brain imaging studies are not required for eligibility if the subject has no neurologic signs or symptoms suggestive of brain metastasis. Subjects with neurological symptoms are recommended to undergo a head CT scan (with or without intravenous contrast) or brain MRI (with or without intravenous contrast) to exclude brain metastasis. If brain imaging studies are performed, they must be negative for CNS disease. Skull bone involvement without neurological impact by prostate cancer is allowed.
  • Treatment with any other investigational agent within 28 days prior to registration. Subjects must not be treated with any other investigational agent while on protocol specified therapy.
  • Prior hemibody external radiation. Any external radiation therapy must have been completed at least 14 days prior to registration. Any toxicity from such therapy must have recovered to ≤ grade 1 per CTCAE version 4 criteria by the time of registration.
  • Clinically significant infections as judged by the treating investigator. Subjects must not have been diagnosed with 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. Subjects should be tested for hepatitis B or C or HIV infection during screening only if they are considered by the investigator to be at high risk for these infections.
  • Known hypersensitivity to bicalutamide.
  • Known gastrointestinal (GI) disease or procedure that could interfere with the GI absorption or tolerance of bicalutamide, including difficulty swallowing oral medications.
  • Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., subjects with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), symptomatic pulmonary embolism within 3 months, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia as determined by the treating physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582749


Locations
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United States, Arizona
University of Arizona Cancer Center at Dignity Health St. Joseph's
Phoenix, Arizona, United States, 85004
United States, Illinois
Illinois CancerCare, P. C.
Peoria, Illinois, United States, 61615
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Iowa
University of Iowa Hopital and Clinics
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Metro Health Cancer Center
Wyoming, Michigan, United States, 49519
United States, Nebraska
GU Research Network, LLC
Omaha, Nebraska, United States, 68130
United States, New York
Integrated Medical Professionals, PLLC
Lake Success, New York, United States, 11042
United States, Texas
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
United States, Wisconsin
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
Ajjai Alva, MD
Hoosier Cancer Research Network
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
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Study Chair: Ajjai Alva, M.D. Hoosier Cancer Research Network

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Responsible Party: Ajjai Alva, MD, Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT02582749     History of Changes
Other Study ID Numbers: HCRN GU13-170
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ajjai Alva, MD, Hoosier Cancer Research Network:
Androgen Deprivation Therapy
Androgen Receptor Antagonist
Radium-223 Dichloride
Placebo

Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Androgens
Bicalutamide
Radium Ra 223 dichloride
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents