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

Primary Purpose

Prostate Cancer, Bone Metastases, Prostate Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LHRH agonist/antagonist
Bicalutamide
Radium-223 dichloride
Sponsored by
Ajjai Alva, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Androgen Deprivation Therapy, Androgen Receptor Antagonist, Radium-223 Dichloride, Placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arizona Cancer Center at Dignity Health St. Joseph's
  • Illinois CancerCare, P. C.
  • Indiana University Melvin and Bren Simon Cancer Center
  • IU Health Central Indiana Cancer Centers
  • University of Iowa Hopital and Clinics
  • University of Michigan Health System
  • Henry Ford Hospital
  • Metro Health Cancer Center
  • GU Research Network, LLC
  • Integrated Medical Professionals, PLLC
  • University of Texas Medical Branch at Galveston
  • Clement J. Zablocki VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Arm A

Experimental Arm B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Radiological Progression-Free Survival (rPFS)
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

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)
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)
Time to First Skeletal-Related Event (SRE)
SRE of subjects on both arms assessed by bone scan or axial imaging
Secondary Neoplasms
Secondary neoplasms of subjects on both arms assessed by bone scan or axial imaging
PSA Complete Response Rates
Subjects on both arms with PSA ≤ 0.2 ng/mL after 7 months of androgen deprivation therapy
PSA Partial Response Rates
Subjects on both arms with PSA between 0.2 and ≤ 4 ng/mL after 7 months of androgen deprivation therapy.
Median Time to Castration Resistance
Castration resistance for subjects on both arms determined by first PSA level increase and/or radiographic progression by first imaging assessment showing progression
2-Year PSA Progression Free Survival (PFS)
PSA PFS for subjects on both arms defined as first PSA level increase
2-Year Overall Survival (OS)
OS for subjects on both arms
12-Week Alkaline Phosphatase (ALP) Normalization
ALP normalization for subjects with abnormal ALP at randomization
Time to ALP Progression
ALP progression of 25% or greater from baseline/nadir for subjects on both arms
Change in Pain Over Time
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.
Analgesic Use by WHO Ladder Score
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.

Full Information

First Posted
October 16, 2015
Last Updated
July 7, 2022
Sponsor
Ajjai Alva, MD
Collaborators
Hoosier Cancer Research Network, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02582749
Brief Title
Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding withdrawn
Study Start Date
April 2016 (Actual)
Primary Completion Date
September 14, 2017 (Actual)
Study Completion Date
September 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ajjai Alva, MD
Collaborators
Hoosier Cancer Research Network, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OUTLINE: This is a multi-center, randomized trial. STRATIFICATION FACTORS: Subjects will be stratified based on serum total alkaline phosphatase at baseline and extent of disease (described below). Randomization will occur within stratification group. Extent of Disease: <6 skeletal metastases with no visceral metastases versus ≥6 skeletal metastases or visceral metastases. Serum total alkaline phosphatase at baseline: normal vs abnormal. Abnormal alkaline phosphatase is defined as > 130 IU/L. Early Induction or Late Induction status will not be a stratification criterion. TREATMENT SCHEDULE: CONTROL ARM A All subjects will receive androgen deprivation therapy with a LHRH agonist (any LHRH agonist such as leuprolide acetate or goserelin acetate is acceptable) or a LHRH antagonist (degarelix) or bilateral orchiectomy, with dosage determined by the treating physician. Route of administration and cycle days will be administered as per package insert. Androgen deprivation therapy with LHRH agonist or LHRH antagonist will be given continuously. All subjects will receive bicalutamide, 50 mg Oral (PO) Daily TREATMENT SCHEDULE: EXPERIMENTAL ARM B All subjects will receive androgen deprivation therapy with a LHRH agonist (any LHRH agonist such as leuprolide acetate or goserelin acetate is acceptable) or a LHRH antagonist (degarelix) or bilateral orchiectomy, with dosage determined by the treating physician. Route of administration and cycle days will be administered as per package insert. Androgen deprivation therapy with LHRH agonist or LHRH antagonist will be given continuously. All subjects will receive bicalutamide, 50 mg oral (PO) daily All subjects will receive Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight, intravenous (IV bolus) every 28 days for 6 injections The following laboratory values must be obtained within 28 days prior to registration for protocol therapy: Hematopoietic: Hemoglobin (Hgb) ≥ 8.0 g/dL (80 g/L) without packed RBC transfusion Platelets ≥ 100 K/mm3 Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 Hepatic: Total Bilirubin ≤ 2 x institutional upper limit of normal (ULN) except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x institutional ULN (≤ 5 x institutional ULN in the presence of liver metastases). Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x institutional ULN (≤ 5 × institutional ULN in the presence of liver metastases). Renal: Estimated Creatinine Clearance by Cockcroft-Gault formula ≥ 30 mL/min

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Bone Metastases, Prostate Neoplasms
Keywords
Androgen Deprivation Therapy, Androgen Receptor Antagonist, Radium-223 Dichloride, Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Arm B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LHRH agonist/antagonist
Other Intervention Name(s)
Per treating physician
Intervention Description
Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex
Intervention Description
Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.
Intervention Type
Radiation
Intervention Name(s)
Radium-223 dichloride
Intervention Description
Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections
Primary Outcome Measure Information:
Title
Radiological Progression-Free Survival (rPFS)
Description
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
Time Frame
From date of randomization to disease progression or death from any cause, up to a maximum of 24 months.
Secondary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months
Title
Time to First Skeletal-Related Event (SRE)
Description
SRE of subjects on both arms assessed by bone scan or axial imaging
Time Frame
From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months
Title
Secondary Neoplasms
Description
Secondary neoplasms of subjects on both arms assessed by bone scan or axial imaging
Time Frame
From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months
Title
PSA Complete Response Rates
Description
Subjects on both arms with PSA ≤ 0.2 ng/mL after 7 months of androgen deprivation therapy
Time Frame
From date of first dose of androgen deprivation therapy (ADT) until completion of 7 cycles (28 weeks)
Title
PSA Partial Response Rates
Description
Subjects on both arms with PSA between 0.2 and ≤ 4 ng/mL after 7 months of androgen deprivation therapy.
Time Frame
From date of first dose of ADT until completion of 7 cycles (28 weeks)
Title
Median Time to Castration Resistance
Description
Castration resistance for subjects on both arms determined by first PSA level increase and/or radiographic progression by first imaging assessment showing progression
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
Title
2-Year PSA Progression Free Survival (PFS)
Description
PSA PFS for subjects on both arms defined as first PSA level increase
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
Title
2-Year Overall Survival (OS)
Description
OS for subjects on both arms
Time Frame
From date of randomization to death from any cause, assessed up to 24 months
Title
12-Week Alkaline Phosphatase (ALP) Normalization
Description
ALP normalization for subjects with abnormal ALP at randomization
Time Frame
From date of randomization until completion of 12 weeks of therapy
Title
Time to ALP Progression
Description
ALP progression of 25% or greater from baseline/nadir for subjects on both arms
Time Frame
From date of randomization until date of ALP progression, assessed up to 24 months
Title
Change in Pain Over Time
Description
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.
Time Frame
From baseline until 30 days after the last treatment, assessed for a maximum of 24 months
Title
Analgesic Use by WHO Ladder Score
Description
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.
Time Frame
From baseline until 30 days after the last treatment, assessed for a maximum of 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajjai Alva, M.D.
Organizational Affiliation
Hoosier Cancer Research Network
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arizona Cancer Center at Dignity Health St. Joseph's
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Illinois CancerCare, P. C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IU Health Central Indiana Cancer Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
University of Iowa Hopital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Metro Health Cancer Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
GU Research Network, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Integrated Medical Professionals, PLLC
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Clement J. Zablocki VA Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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