Metastatic Prostate CancerPhase 2NCT02278055
Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study testing Radium-223 in people with Metastatic Prostate Cancer and Pain, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer, Pain
- What is being tested?
- Radium-223
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Oct 2014to 2 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina
Chapel Hill, North Carolina, 27514
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, 10065
About this study
Official title: Phase II Open, Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer
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
- Being tested
- Radium-223
- Keywords
- Radium-223, 14-098, Prostate Cancer Clinical Trials Consortium
- Medical subject headings
- Prostatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Radium-223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
Number of Participants With Changes in Bone Alkaline Phosphatase (ALP)
Number of participants with changes 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.
Measured: 12 weeks
Number of Participants With Changes in Other Bone Markers:
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study start8 Oct 2014
- Primary completion2 Feb 2022
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, New York Presbyterian Hospital
- Responsible party
- Sponsor
- Investigators
- Michael Morris, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278055
- Sponsor's protocol ID
- 14-098
- Other IDs
- c13-124
- Status last verified
- Aug 2021
- First submitted
- 25 Oct 2014
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open, Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02278055
- Acronym / sponsor ID
- 14-098
- Conditions
- Metastatic Prostate Cancer, Pain
- Keywords
- Radium-223, 14-098, Prostate Cancer Clinical Trials Consortium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of North Carolina, New York Presbyterian Hospital
- Study start
- 8 Oct 2014 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 | Experimental | Drug: Radium-223Radium 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium-223 | Drug | Radium-223 |
Primary outcome
Percentage of Participants With 30% Decline in the Brief Pain Inventory (BPI) Worst Pain Item From Baseline to Week 8
Time frame: 8 weeks
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.
2 secondary outcomes
Number of Participants With Changes in Bone Alkaline Phosphatase (ALP)
Time frame: 12 weeks
Number of Participants With Changes in Other Bone Markers:
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Morris, MD principal investigator
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radium-223 in people with Metastatic Prostate Cancer and Pain, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With 30% Decline in the Brief Pain Inventory (BPI) Worst Pain Item From Baseline to Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.