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

NCT02278055 | Completed Phase 2 Results

• 2 other identifiers: 14-098c13-124
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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

Keywords

Radium-223; 14-098; Prostate Cancer Clinical Trials Consortium

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 30% Decline in the Brief Pain Inventory (BPI) Worst Pain Item From Baseline to Week 8

  Defined as a 30% decline in the Brief Pain Inventory/BPI worse pain item from baseline to week 8, with a confirmed reduction at week 12 without an escalation of the subject's pain regimen from Step 1 to Step 2 or Step 2 to Step 3 of the WHO analgesic ladder.) The baseline BPI worst pain score average will be based on the worst pain scores completed by the participant in the 7 consecutive pretreatment days. A minimum of 4 days of pain scores must be completed by the participant in the 7 day window in order to calculate the average worst pain score. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.

  8 weeks

Secondary Outcomes (2)

• Number of Participants With Changes in Bone Alkaline Phosphatase (ALP)

  12 weeks

• Number of Participants With Changes in Other Bone Markers:

  1 year

Study Arms (1)

Radium-223

EXPERIMENTAL

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.

Drug: Radium-223

Interventions

Radium-223 DRUG

Radium-223

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of North Carolina: collaborator
• New York Presbyterian Hospital: collaborator

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms; Pain

Interventions

Radium-223

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michael Morris, MD
• Organization: Memorial Sloan Kettering Cancer Center

morrism@MSKCC.ORG

646-422-4469

Study Officials

• Michael Morris, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2014
• First Posted: October 29, 2014
• Study Start: October 8, 2014
• Primary Completion: February 2, 2022
• Study Completion: February 2, 2022
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2021-08

Locations

US (3)