Status:
COMPLETED
Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
University of North Carolina
New York Presbyterian Hospital
Conditions:
Metastatic Prostate Cancer
Pain
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02278055
Start Date
October 8 2014
End Date
February 2 2022
Last Update
April 7 2023
Active Locations (3)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, United States, 10065
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27514