- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135484
Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases
An Observation, Open Label Study of Alpharadin (Radium 223) in Patients With Castrate Resistant Prostate Cancer Bone Metastases
Study Overview
Detailed Description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive radium-223 by vein over about 1 minute at the beginning of every study cycle for 6 cycles. Every 4 weeks is a study cycle.
You will need to be well hydrated before each dose by drinking at least 2-3 cups (8 ounces each) of water.
Do not take additional drugs, including over-the-counter products and herbal/alternative drugs, during the study without talking with the study doctor first.
Study Visits:
You will have a study visit before each dose of radium-223. The following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.
- Urine will be collected for biomarker testing.
At Week 12, you will have bone marrow biopsy and aspiration performed to check the status of the disease and for biomarker testing.
At Week 24 the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests, as well as to check your PSA and testosterone levels.
Length of Study:
You may receive the study drug for up to 6 doses. You will be taken off study early if the disease gets worse, if you have intolerable side effects, if your study doctor thinks it is in your best interest to stop, or if you are unable to follow study directions.
End of Treatment Visit:
After you stop receiving the study drug for any reason, the following tests and procedures will be performed:
- You will have a physical exam.
- You will have a sodium fluoride PET/CT scan to check the status of the disease.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.
- Urine will be collected for biomarker testing.
- You will have a bone marrow aspiration and biopsy performed for biomarker testing.
Long-Term Follow-Up:
The study staff will check up on you about every 6 months after your last dose of study drug. This will consist of a phone call, an e-mail, or a review of your medical records. If you are contacted by phone, the call will last about 5 minutes.
This is an investigational study. Radium-223 is FDA approved and commercially available for the treatment of metastatic CRPC that has spread to the bones but not to other organs. It is investigational to look for biomarkers that may be related to CRPC in patients who are receiving radium-223.
The study doctor can explain how the study drug is designed to work.
Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically proven adenocarcinoma of the prostate with evidence for skeletal metastases on bone scan and/or CT scan and symptoms judged to be related to bone metastases
- Eastern Cooperative Oncology Group (ECOG) performance status < 2. (Karnofsky Performance Status >/= 50%)
- Serum testosterone levels < 50ng/ml
- Ongoing gonadal androgen deprivation therapy with Luteinizing Hormone-Releasing Hormone (LHRH) analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on standard dosing of LHRH analogue therapy at appropriate frequency for the duration of the study
- Life expectancy of at least 12 weeks (3 months)
- Discontinue any steroids prescribed to specifically treat prostate cancer (for e.g as a secondary hormonal manipulation or for cord compression) > 4 weeks prior to study drug. Steroids chronically prescribed for a non-cancer-related illness [e.g. asthma or chronic obstructive pulmonary disease (COPD)] that is well controlled with medical management are permissible to an equivalent of <10 mg Prednisone daily. Note: Steroids may be administered during the study as supportive care
- Laboratory Requirements: a.) white blood cell (WBC) count > 3,000/ul; b.) Absolute Neutrophil Count (ANC) > 1,500/ul; c.) Hemoglobin >/= 8.0 g/dL independent of transfusion; d.) Platelet count >/= 100,000/uL; e.) Serum albumin >/= 3.0 g/dL; f.) Calculated or measured creatinine clearance > 30 mL/min
- All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF)
- Patient must be willing and able to comply with protocol requirements. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
- Patients must also have signed an authorization for the release of their protected health information
Exclusion Criteria:
- Treatment with cytotoxic chemotherapy within previous 4 weeks of protocol treatment, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks prior to protocol treatment (however, ongoing neuropathy is permitted)
- Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-223 dichloride) for the treatment of bony metastases
- Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
- Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)
- Known brain metastases
- Lymphadenopathy exceeding 6 cm in short-axis diameter
- Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
- Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression
- Any other serious illness or medical condition, such as but not limited to: a) Any infection >/= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 2; b) Cardiac failure New York Heart Association (NYHA) III or IV; c) Crohn's disease or ulcerative colitis; d) Bone marrow dysplasia; e) Fecal incontinence
- Inability to comply with the protocol and/or not willing or not available for follow-up assessments
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
- Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than Ra 223 dichloride
- Prior use of Ra-223 dichloride, Strontium or Samarium
- Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
- Major surgery within 30 days prior to start of study drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alpharadin
Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
|
50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (Favorable and Unfavorable )
Time Frame: 3.6 years
|
Overall survival is measured in months from the time of enrollment until death.
Participants who survived longer then the median survival rate of 24.3 months were assigned favorable survival.
Participants who survived less than 24.3 months were assigned unfavorable survival.
|
3.6 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Araujo, MD,PHD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0933
- NCI-2014-02016 (Registry Identifier: NCI CTRP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Alpharadin
-
M.D. Anderson Cancer CenterBayerCompletedSarcomaUnited States
-
University of UtahCompleted
-
BayerCompletedBone Metastases | Hormone Refractory Prostate CancerItaly, Spain, Hong Kong, Canada, United Kingdom, France, Australia, United States, Germany, Brazil, Israel, Netherlands, Norway, Belgium, Sweden, Czech Republic, Poland, Singapore, Slovakia
-
University of Southern CaliforniaNational Cancer Institute (NCI)Active, not recruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer | Prostate Carcinoma Metastatic in the BoneUnited States
-
M.D. Anderson Cancer CenterBayerCompleted
-
University of WashingtonBayerRecruitingCastration-Resistant Prostate Carcinoma | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Metastatic Malignant Neoplasm in the Bone | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8United States
-
National Cancer Institute (NCI)RecruitingClear Cell Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Malignant Neoplasm in the Bone | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Kidney Medullary Carcinoma | Advanced Renal Cell Carcinoma | Unclassified Renal Cell CarcinomaUnited States
-
National Cancer Institute (NCI)RecruitingCastration-Resistant Prostate Carcinoma | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Metastatic Malignant Neoplasm in the Lymph NodesUnited States
-
National Cancer Institute (NCI)SuspendedCastration-Resistant Prostate Carcinoma | Stage IVB Prostate Cancer AJCC v8 | Metastatic Prostate AdenocarcinomaUnited States
-
National Cancer Institute (NCI)RecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Metastatic Malignant Neoplasm in the Bone | Metastatic HER2-Negative Breast CarcinomaUnited States