Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases

NCT02135484 | Completed Results FDA Drug

• 2 other identifiers: 2013-0933NCI-2014-02016
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Adenocarcinoma of the prostate; Castrate resistant prostate cancer; CRPC; Skeletal metastases; Alpharadin; Xofigo; Radium-223 chloride; Radium-223 dichloride

Outcome Measures

Primary Outcomes (1)

• Overall Survival (Favorable and Unfavorable )

  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

Study Arms (1)

Alpharadin

EXPERIMENTAL

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).

Drug: Alpharadin

Interventions

Alpharadin DRUG

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).

Also known as: Xofigo, Radium-223 chloride, Radium-223 dichloride

Alpharadin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bayer: collaborator
• Prostate Cancer Foundation: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Corn PG, Yu G, Fan Y, Zhang M, Troncoso P, Surasi DS, Liu S, Ajani JA, Logothetis CJ, Wang G, Panaretakis T, Lin SH. Spatial immune profiling of bone-metastatic castration-resistant prostate cancer reveals radium-223 immunomodulates the bone-tumor microenvironment. Prostate Cancer Prostatic Dis. 2025 Dec 26. doi: 10.1038/s41391-025-01069-1. Online ahead of print.

  PMID: 41454189 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: John C. Araujo, Associate Professor, Genitourinary Medical Oncology
• Organization: UT MD Anderson Cancer Center

johna@mdanderson.org

(713) 792-2830

Study Officials

• John Araujo, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: September 19, 2014
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2022-02

Locations

US (1)