Bony Metastases From Castrate Refractory Prostate CancerNCT03368989
The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.
An observational study of Bony Metastases From Castrate Refractory Prostate Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
To describe the changes seen on bone scan and correlate them with changes in relative chemical biomarkers, patient's functional status and level of pain. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bony Metastases From Castrate Refractory Prostate Cancer
- What is being tested?
- Radium-223 dichloride
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2014to 7 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Males presenting with prostate cancer.
Who may be able to join
- Prostate cancer patients scheduled for treatment with Radium-223.
Who cannot join
- Patients not completing their treatment regimen for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
To describe the changes seen on bone scan and correlate them with changes in relative chemical biomarkers, patient's functional status and level of pain.
- Being tested
- Radium-223 dichloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 dichlorideDrug
Also called Xofigo
Previously known as Alpharadin, Radium-223 dichloride is a calcium-mimetic, alpha emitting radiopharmaceutical, which introduces double-stranded DNA breaks in metastatic cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| treatment with radium-223 Dichloride (Xofigo) | Not described Receives: Drug: Radium-223 dichloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of osteoblastic bone lesions
number of lesions specified before and after the treatment with a bone scan
Measured: Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment)
Secondary outcomes (9)
functional status as indicated by score on the Eastern Cooperative Oncology Group (ECOG) performance scale
The ECOG scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The possible scores on the scale are 0 to 5, with 0 being the best outcome and 5 being the worst outcome, details of each score are listed below.
Grade 0 = Fully active, able to carry on all pre-disease performance without restriction Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Grade 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Grade 5 = Dead
Measured: Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
pain level as assessed by numeric rating score
As assessed using numeric rating score from 1-10 with 10 being the highest level of pain
Measured: Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
(PSA) prostate specific antigen level
normal level should be 4.0 ng/mL. value is measured after each dose
Measured: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
(ALP) alkaline phosphatase level
The normal value for alkaline phosphatase is 53 to 128 U/L.
Measured: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Hemoglobin level
The normal level for males is 14 to 18 g/dl
Measured: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Platelet level
A normal platelet count ranges from 150,000 to 450,000 platelets
Measured: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Neutrophil count
The normal range for neutrophils is 2.5-7.5 x 10 9 /L
Measured: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Creatinine level
Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL)
Measured: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
white blood cell count
The typical white blood cell count varies from 4,000 to 10,000 cells per mm3.
Measured: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start11 Feb 2014
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bony Metastases From Castrate Refractory Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isis W Gayed, The University of Texas Health Science Center, Houston
- Investigators
- Isis W Gayed, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368989
- Sponsor's protocol ID
- HSC-MS-14-0113
- Status last verified
- Jun 2019
- First submitted
- 13 Nov 2017
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.
- ClinicalTrials.gov ID
- NCT03368989
- Acronym / sponsor ID
- HSC-MS-14-0113
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 11 Feb 2014 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the changes seen on bone scan and correlate them with changes in relative chemical biomarkers, patient's functional status and level of pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment with radium-223 Dichloride (Xofigo) | – | Drug: Radium-223 dichloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males presenting with prostate cancer.
Key inclusion criteria (1 listed)
- Prostate cancer patients scheduled for treatment with Radium-223.
Key exclusion criteria (1 listed)
- Patients not completing their treatment regimen for any reason
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 dichlorideAlso: XofigoPreviously known as Alpharadin, Radium-223 dichloride is a calcium-mimetic, alpha emitting radiopharmaceutical, which introduces double-stranded DNA breaks in metastatic cancer cells. | Drug | treatment with radium-223 Dichloride (Xofigo) |
Primary outcome
Change in number of osteoblastic bone lesions
Time frame: Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment)
number of lesions specified before and after the treatment with a bone scan
9 secondary outcomes
functional status as indicated by score on the Eastern Cooperative Oncology Group (ECOG) performance scale
Time frame: Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
pain level as assessed by numeric rating score
Time frame: Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
(PSA) prostate specific antigen level
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
(ALP) alkaline phosphatase level
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Hemoglobin level
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Platelet level
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Neutrophil count
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Creatinine level
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
white blood cell count
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Individual participant dataSharing planned: No
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.
Isis W Gayed, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bony Metastases From Castrate Refractory Prostate Cancer, run by The University of Texas Health Science Center, Houston at 1 site 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 1 inclusion and 1 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in number of osteoblastic bone lesions (time frame: Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment)). 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 11 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.