Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases

• Status: Completed
• Trial end date: 2020-11-11
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Bayer; Prostate Cancer Foundation
• Treatments: Radium Ra 223 dichloride; Succinylcholine

Criteria

Inclusion Criteria:

1. 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

2. Eastern Cooperative Oncology Group (ECOG) performance status < 2. (Karnofsky Performance Status >/= 50%)

3. Serum testosterone levels < 50ng/ml

4. 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

5. Life expectancy of at least 12 weeks (3 months)

6. 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

7. 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

8. 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)

9. 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

10. Patients must also have signed an authorization for the release of their protected health information

Exclusion Criteria:

1. 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)

2. 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

3. Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)

4. Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)

5. Known brain metastases

6. Lymphadenopathy exceeding 6 cm in short-axis diameter

7. Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis

8. Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression

9. 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

10. Inability to comply with the protocol and/or not willing or not available for follow-up assessments

11. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

12. Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than Ra 223 dichloride

13. Prior use of Ra-223 dichloride, Strontium or Samarium

14. 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)

15. Major surgery within 30 days prior to start of study drug