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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278055
Recruitment Status : Active, not recruiting
First Posted : October 29, 2014
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
University of North Carolina
New York-Presbyterian Hospital Cornell Medical Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE October 25, 2014
First Posted Date  ICMJE October 29, 2014
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE October 8, 2014
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
pain response [ Time Frame: 8 weeks ]
(defined as a 30% decline in the BPI worse pain item from baseline to week 8, with a confirmed reduction at week 12 without an escalation of the subjects pain regimen from Step 1 to Step 2 or Step 2 to Step 3 of the WHO analgesic ladder.)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • Changes in Bone Alkaline phosphatase (ALP) [ Time Frame: 12 weeks ]
    Percentage of change from baseline to 12 weeks (or earlier for those who discontinue study therapy) Maximum change (rise or fall) in bone Alkaline phosphatase (ALP) during the treatment period reported for each patient as a waterfall plot
  • Changes in other bone markers: [ Time Frame: 1 year ]
    Serum C-telopeptide (sCTX-1) N-terminal propeptide of procollagen type 1 (PINP) Changes in total-ALP will be defined as for bone-ALP above
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer
Official Title  ICMJE Phase II Open, Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Metastatic Prostate Cancer
  • Pain
Intervention  ICMJE Drug: Radium-223
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: Radium-223
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2018)
29
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
15
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02278055
Other Study ID Numbers  ICMJE 14-098
c13-124 ( Other Identifier: Prostate Cancer Clinical Trials Consortium )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • University of North Carolina
  • New York-Presbyterian Hospital Cornell Medical Center
Investigators  ICMJE
Principal Investigator: Michael Morris, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP