A Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to look for markers of how Ra-223 improves the lives of men with prostate cancer. This study makes use of Ra-223 in the standard FDA-approved way, but adds non-standard testing in an attempt to gain insight about how the drug works and how best to track patients who are receiving the drug.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Bayer
• Treatments: Radium Ra 223 dichloride

Criteria

Inclusion Criteria:

• Male age ≥ 18 years.

• Histologically or cytologically confirmed adenocarcinoma of the prostate. Life expectancy of at least 6 months.

• ECOG performance status of zero, one, or two.

• Bone-predominant metastatic CRPC: at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node metastasis is allowed).

• Symptomatic as defined by either of the following:

• (a) Regular use of analgesic medication for cancer-related bone pain (≥ level 1; WHO ladder for cancer pain), or

• (b) Treatment with EBRT for bone pain (though EBRT must be completed ≥12 weeks prior to enrollment in this trial).

• Judged by investigator to have progressive disease sufficient to clinically justify standard-of-care radium-223 treatment.

• Subjects must be able to understand and be willing to sign the written informed consent form.

• All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF).

• No intention to use cytotoxic chemotherapy within the next 6 months. Subjects must agree to use adequate contraception beginning at the signing of the ICF until at least 6 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator.

• Acceptable hematology and serum biochemistry screening values:

• White Blood Cell Count (WBC) ≥ 3,000/mm3

• Absolute Neutrophil Count (ANC) ≥ 1,500/mm3

• Platelet (PLT) count ≥ 100,000/mm3

• Hemoglobin (HGB) ≥10 g/dl (Please note: it is acceptable from the standpoint of study eligibility to undergo transfusion in order to achieve hemoglobin ≥ 10 g/dl)

• Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

• Creatinine ≤ 1.5 x ULN

• Albumin > 25 g/L

• Willing and able to comply with the protocol, including follow-up visits and examinations.

Exclusion Criteria:

• Treatment with cytotoxic chemotherapy within previous 28 days, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 28 days previous (however, ongoing neuropathy is permitted).

• Received any investigational compound within 28 days prior to the first dose of study drug or planned during the treatment period or follow-up.

• Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases.

• Received previous radiotherapy to approximately >25% of bone marrow.

• 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.

• Presence of 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:

• Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2

• Cardiac failure New York Heart Association (NYHA) III or IV

• Crohn's disease or ulcerative colitis

• Known bone marrow dysplasia

• Fecal incontinence.

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