Prostate CancerPhase 2NCT02582749
Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases
A Phase 2 study testing LHRH agonist/antagonist, Bicalutamide and Radium-223 dichloride in people with Prostate Cancer and Bone Metastases, run by Ajjai Alva, MD at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Bone Metastases, Prostate Neoplasms
- What is being tested?
- LHRH agonist/antagonist, Bicalutamide and Radium-223 dichloride
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2016to 14 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Henry Ford Hospital
Detroit, Michigan, 48202
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
University of Iowa Hopital and Clinics
Iowa City, Iowa, 52242
Integrated Medical Professionals, PLLC
Lake Success, New York, 11042
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, 53295
GU Research Network, LLC
Omaha, Nebraska, 68130
Illinois CancerCare, P. C.
Peoria, Illinois, 61615
University of Arizona Cancer Center at Dignity Health St. Joseph's
Phoenix, Arizona, 85004
Metro Health Cancer Center
Wyoming, Michigan, 49519
About this study
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
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.
Read the 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
- Conditions
- Prostate Cancer, Bone Metastases, Prostate Neoplasms
- Being tested
- LHRH agonist/antagonist, Bicalutamide, Radium-223 dichloride
- Keywords
- Androgen Deprivation Therapy, Androgen Receptor Antagonist, Radium-223 Dichloride, Placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHRH agonist/antagonistDrug
Also called Per treating physician
Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.
BicalutamideDrug
Also called Casodex
Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.
Radium-223 dichlorideRadiation
Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections
| Study group | Role | What they receive |
|---|---|---|
| Control Arm A | Active comparator | 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. Receives: Drug: LHRH agonist/antagonist; Drug: Bicalutamide |
| Experimental Arm B | Experimental | 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. Receives: Drug: LHRH agonist/antagonist; Drug: Bicalutamide; Radiation: Radium-223 dichloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From date of randomization to disease progression or death from any cause, up to a maximum of 24 months.
Secondary outcomes (12)
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)
Measured: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months
Time to First Skeletal-Related Event (SRE)
SRE of subjects on both arms assessed by bone scan or axial imaging
Measured: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months
Secondary Neoplasms
Secondary neoplasms of subjects on both arms assessed by bone scan or axial imaging
Measured: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months
PSA Complete Response Rates
Subjects on both arms with PSA ≤ 0.2 ng/mL after 7 months of androgen deprivation therapy
Measured: From date of first dose of androgen deprivation therapy (ADT) until completion of 7 cycles (28 weeks)
PSA Partial Response Rates
Subjects on both arms with PSA between 0.2 and ≤ 4 ng/mL after 7 months of androgen deprivation therapy.
Measured: From date of first dose of ADT until completion of 7 cycles (28 weeks)
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
Measured: 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
2-Year PSA Progression Free Survival (PFS)
PSA PFS for subjects on both arms defined as first PSA level increase
Measured: From date of randomization to first occurrence of PSA progression, symptomatic deterioration, or death due to any cause, assessed up to 24 months
2-Year Overall Survival (OS)
OS for subjects on both arms
Measured: From date of randomization to death from any cause, assessed up to 24 months
12-Week Alkaline Phosphatase (ALP) Normalization
ALP normalization for subjects with abnormal ALP at randomization
Measured: From date of randomization until completion of 12 weeks of therapy
Time to ALP Progression
ALP progression of 25% or greater from baseline/nadir for subjects on both arms
Measured: From date of randomization until date of ALP progression, assessed up to 24 months
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.
Measured: From baseline until 30 days after the last treatment, assessed for a maximum of 24 months
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.
Measured: From baseline until 30 days after the last treatment, assessed for a maximum of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startApr 2016
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajjai Alva, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Sponsor-investigator, Ajjai Alva, MD, Hoosier Cancer Research Network
- Investigators
- Ajjai Alva, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582749
- Sponsor's protocol ID
- HCRN GU13-170
- Status last verified
- Jul 2022
- First submitted
- 16 Oct 2015
- Last updated
- 11 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02582749
- Acronym / sponsor ID
- HCRN GU13-170
- Conditions
- Prostate Cancer, Bone Metastases, Prostate Neoplasms
- Keywords
- Androgen Deprivation Therapy, Androgen Receptor Antagonist, Radium-223 Dichloride, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ajjai Alva, MDUniversity, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Apr 2016 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 9 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm A | Active comparator | Drug: LHRH agonist/antagonist, Drug: BicalutamideAll 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. |
| Experimental Arm B | Experimental | Drug: LHRH agonist/antagonist, Drug: Bicalutamide, Radiation: Radium-223 dichlorideAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LHRH agonist/antagonistAlso: Per treating physicianTreating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle. | Drug | Control Arm A, Experimental Arm B |
| BicalutamideAlso: CasodexBicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle. | Drug | Control Arm A, Experimental Arm B |
| Radium-223 dichlorideRadium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections | Radiation | Experimental Arm B |
Primary outcome
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
12 secondary outcomes
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
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
Secondary Neoplasms
Time frame: From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months
PSA Complete Response Rates
Time frame: From date of first dose of androgen deprivation therapy (ADT) until completion of 7 cycles (28 weeks)
PSA Partial Response Rates
Time frame: From date of first dose of ADT until completion of 7 cycles (28 weeks)
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
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
2-Year Overall Survival (OS)
Time frame: From date of randomization to death from any cause, assessed up to 24 months
12-Week Alkaline Phosphatase (ALP) Normalization
Time frame: From date of randomization until completion of 12 weeks of therapy
Time to ALP Progression
Time frame: From date of randomization until date of ALP progression, assessed up to 24 months
Change in Pain Over Time
Time frame: From baseline until 30 days after the last treatment, assessed for a maximum of 24 months
Analgesic Use by WHO Ladder Score
Time frame: From baseline until 30 days after the last treatment, assessed for a maximum of 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajjai Alva, M.D. study chair
Hoosier Cancer Research Network
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LHRH agonist/antagonist, Bicalutamide and Radium-223 dichloride in people with Prostate Cancer and Bone Metastases, run by Ajjai Alva, MD at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.