Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer

NCT ID: NCT02278055

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-08
• Study Completion Date: 2022-02-02

Brief Summary

The purpose of this study is to find out if Radium-223 is effective in reducing cancer pain within 12 weeks of treatment. In order to see if Radium-223 is effective, the patient's level of pain will be followed throughout the study.

Conditions

Metastatic Prostate Cancer; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Radium-223

Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.

Group Type: EXPERIMENTAL

Radium-223

Intervention Type: DRUG

Interventions

Radium-223

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males aged 18 years of age and above
• Histological or cytological proof of prostate adenocarcinoma
• Castrate serum testosterone level: ≤50 ng/dL (≤1.7 nmol/L)
• Patients who have experienced disease progression despite initial hormonal therapy, either by orchiectomy or by using a GnRH agonist in combination with an anti-androgen, must first progress through anti- androgen withdrawal prior to being eligible. The minimum time frame to document failure of anti-androgen withdrawal will be four weeks. Patients on second-line (or beyond) hormonal maneuvers, and patients who had no PSA decline on combined androgen blockade as first line therapy, need not progress through AAW in order to be eligible.
• Known progressive castration-resistant disease, defined as:

• Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first treatment, each measurement at least one week apart. Serum PSA at screening ≥ 2 ng/mL or
• Documented appearance of new lesions by bone scintigraphy
• ECOG Performance Status of 0-2 2 or more bone metastases demonstrated on bone scintigraphy
• Pain at baseline as measured by a BPI worst pain score average of ≥ 3. The BPI worst pain score average will be based on the worst pain scores completed by the patient in the 7 consecutive pretreatment days. A minimum of 4 days of pain scores must be completed by the patient in the 7 day window in order to calculate the average worst pain score. The investigator will optimize the subject's pain regimen prior to study entry.
• Normal organ function with acceptable initial laboratory values:

• WBC ≥ 3 x 109 /L
• ANC ≥ 1.5 x 109 /L
• Platelets ≥ 100 x 109 /L
• Hemoglobin ≥ 9.0 g/dL
• Creatinine < 1.5 x institutional upper limit of normal (ULN)
• Bilirubin ≤ 1.5 x ULN
• AST/ALT ≤ 2.5 x ULN
• Albumin > 25 g/L
• All acute toxicities as a result of any prior treatment must have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF) [Note: Ongoing grade 2 neuropathy as a result of treatment with a cytotoxic chemotherapy regimen is permitted]
• Life expectancy of at least 6 months
• Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
• Willing and able to comply with the protocol, including follow-up visits, examinations as well as having the ability to self-report pain and fatigue using a Patient Reported Outcome (PRO) instrument
• Willingness to use adequate methods of contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug

Exclusion Criteria

• Prior exposure to Radium-223
• Received an investigational therapy within the 4 weeks prior to registration or is scheduled to receive one during the treatment period
• Received a new anti-cancer agent within 4 weeks prior to registration
• Received external beam radiotherapy within 4 weeks prior registration
• Received systemic therapy with radionuclides (e.g. strontium-89, samarium-153, rhenium-186 or rhenium-188) for the treatment of bone metastases
• Treatment with cytotoxic chemotherapy within 4 weeks prior to registration
• Symptomatic nodal disease, i.e. scrotal, penile or leg edema. Visceral metastases (including cerebral metastases) from CRPC (>2 lung and/or liver metastases [size ≥2cm]; Lymphadenopathy exceeding 6 cm in short-axis diameter or any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis), as assessed by CT, MRI or chest X-ray within the 8 weeks prior registration.
• Concurrent chemotherapy. Patients may be on other non-chemotherapy anti-cancer treatments, per FDA labeling of Radium-223, provided that these are not changed during the primary pain assessment period Major surgery within 30 days prior to registration.
• Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression.
• Patients with a, "currently active," second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Patients who have completed therapy for a prior malignancy and are free of disease for ≥3 years are eligible.
• 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
• Bone marrow dysplasia
• Fecal incontinence
• Any other condition which, in the opinion of the Investigator, would make the subject unsuitable for trial participation
• NOTE: Any patient found to be ineligible prior to treatment initiation will require re-screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

New York Presbyterian Hospital

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

c13-124

Identifier Type: OTHER

Identifier Source: secondary_id

14-098

Identifier Type: -

Identifier Source: org_study_id