Prostate NeoplasmPhase 2NCT01240551
F-18 Sodium Fluoride in Prostate Cancer
A Phase 2 study testing F-18 NaF in people with Prostate Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Sodium fluoride (NaF) is a common compound that is found in various foods and can be used to increase bone strength. When this compound is added to a small dose of radiation (F-18), it collects in the bones, with higher amounts in areas where the bone is rapidly changing, such as the site of a healing… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Neoplasm
- What is being tested?
- F-18 NaF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2010to 31 May 2013
- 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
- Participants must have a clinical course consistent with prostate cancer and have available documentation of prostate adenocarcinoma from either the National Cancer Institute (NCI) or from an outside pathology laboratory.
- Participant must have:
- A history of PSA of > 10ng/mL or a history of PSA doubling time of less than or equal to 6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP bone scan, CT etc)
- OR
- Any PSA level and known bone metastatic disease on standard of care imaging (Tc-99m MDP bone scan, CT etc).
- Ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Who cannot join
- Participants with severe claustrophobia unresponsive to oral anxiolytics.
- Subjects weighing greater than 350 lbs (weight limit for scanner table), or unable to fit within the imaging gantry.
- Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer
Background:
- Sodium fluoride (NaF) is a common compound that is found in various foods and can be used to increase bone strength. When this compound is added to a small dose of radiation (F-18), it collects in the bones, with higher amounts in areas where the bone is rapidly changing, such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able to better measure the changes in the bone that may indicate that a certain type of cancer (such as prostate cancer) has spread to the bones.
Read more
Objectives:
- To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and their change over time and compare with clinical course, in individuals with prostate cancer.
- To determine the smallest amount of change in the bone tumors that F-18 NaF can accurately measure.
Eligibility:
- Men at least 18 years of age who have been diagnosed with prostate cancer and have had imaging studies to determine whether the cancer has spread to their bones. Both patients with and without known bone involvement will be enrolled.
Design:
- Participants will be screened with a physical examination, medical history, and imaging studies, and will provide baseline blood samples to evaluate kidney function.
- For the study, participants will have two F-18 NaF PET/CT scans on separate days for baseline. These repeat scans will be used to determine the amount of change that is due to the imaging process alone (i.e. not due to the disease getting better or worse. Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection. Participants will be watched closely for side effects from the F-18 NaF until the scans are done, and will be asked to drink plenty of water to void the F-18 NaF from the body after the scans.
- As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8 months after the first scans and then one 10 to 14 months after the first scans. Participants will provide additional blood samples before the followup scans.
Read the detailed description
Background:
- Evaluating response to therapy in prostate cancer is limited by the inability to quantify bony metastatic disease
- F-18 sodium fluoride (NaF) is a PET radiopharmaceutical which localizes in regions of bony turnover, and was the 1st bone scan agents (prior to Tc-99m MDP (methylene diphosphonate) availability)
- Today s high sensitivity PET cameras can image the distribution of F-18 NaF as a whole body volume and permit quantification of uptake over time. The addition of co-registered CT increases the diagnostic accuracy for detection of metastatic disease
Primary Objective:
-To evaluate the feasibility of using NaF PET/CT to quantitatively measure the extent of bony metastatic disease in patients with prostate cancer in patients
- To determine the intra-patient reproducibility of F-18 NaF PET/CT
- To explore the relationship between the biodistribution changes in F-18 NaF PET/CT parameters and the clinical response
Eligibility:
- Participant must have pathology proven adenocarcinoma of the prostate.
- Participant must have
- A history of PSA > 10ng/mL or a history of PSA doubling time of less than or equal to 6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP bone scan, CT etc).
OR
--Any PSA (prostate specific antigen) level and known bone metastatic disease on standard of care imaging (Tc-99m MDP bone scan, CT etc.)
- Participant must be 18 years or older and have ECOG (Eastern Cooperative Oncology Group) Performance grade of 0 to 2
- Ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Design:
This is a pilot, 2-arm, open label study of patients with prostate cancer. One arm will accrue patients with known bone metastases and the second will accrue patient at risk of developing bone metastases (30 patients per group; total enrollment 60 patients). As it is possible that there will be different rates of bone lesion detection dependent on hormone responsiveness of the tumors, further stratification (castrate sensitive vs. castrate resistant tumor) may be performed to evaluate for predominant trends. All participants will undergo a static F-18 NaF imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. The change in bone uptake of F-18 NaF will be measured, reproducibility determined, and preliminary comparisons with clinical response will be made.
- Conditions
- Prostate Neoplasm
- Being tested
- F-18 NaF
- Keywords
- Imaging, Bone Metastasis, Bone Scan, Radiopharmaceutical, Pet Scan, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 NaFDrug
All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
| Study group | Role | What they receive |
|---|---|---|
| Mets via NaF-18 PET/CT | Active comparator | Patients with known bone metastases (i.e. mets). Receives: Drug: F-18 NaF |
| No-Mets via NaF-18 PET/CT | Active comparator | Patients with no clinical evidence of bone metastases Receives: Drug: F-18 NaF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Present or Not Present Bone Metastasis
Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.
Measured: Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.
Secondary outcomes (1)
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Measured: date treatment consent signed to date off study, approximately 52.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study start30 Nov 2010
- Primary completion31 May 2013
- Study completion31 May 2013
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Karen Kurdziel, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Karen A Kurdziel, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240551
- Sponsor's protocol ID
- 110021
- Other IDs
- 11-C-0021
- Status last verified
- Oct 2017
- First submitted
- 11 Nov 2010
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized patient images and associated Prostate Specific-Antigen (PSA) and Gleason Scores.
Publications
Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.
PubMed 18309951Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
PubMed 15470213Grant FD, Fahey FH, Packard AB, Davis RT, Alavi A, Treves ST. Skeletal PET with 18F-fluoride: applying new technology to an old tracer. J Nucl Med. 2008 Jan;49(1):68-78. doi: 10.2967/jnumed.106.037200. Epub 2007 Dec 12.
PubMed 18077529Kurdziel KA, Shih JH, Apolo AB, Lindenberg L, Mena E, McKinney YY, Adler SS, Turkbey B, Dahut W, Gulley JL, Madan RA, Landgren O, Choyke PL. The kinetics and reproducibility of 18F-sodium fluoride for oncology using current PET camera technology. J Nucl Med. 2012 Aug;53(8):1175-84. doi: 10.2967/jnumed.111.100883. Epub 2012 Jun 22.
PubMed 22728263
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer
- ClinicalTrials.gov ID
- NCT01240551
- Acronym / sponsor ID
- 110021
- Conditions
- Prostate Neoplasm
- Keywords
- Imaging, Bone Metastasis, Bone Scan, Radiopharmaceutical, Pet Scan, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 30 Nov 2010 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Posted 24 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Sodium fluoride (NaF) is a common compound that is found in various foods and can be used to increase bone strength. When this compound is added to a small dose of radiation (F-18), it collects in the bones, with higher amounts in areas where the bone is rapidly changing, such as the site of a healing fracture or a tumor. By giving F-18 NaF before a combined positron emission tomography/ computed tomography (PET/CT) scan, researchers hope to be able to better measure the changes in the bone that may indicate that a certain type of cancer (such as prostate cancer) has spread to the bones.
Objectives:
- To evaluate the effectiveness of F-18 NaF in imaging studies to measure bone tumors and their change over time and compare with clinical course, in individuals with prostate cancer.
- To determine the smallest amount of change in the bone tumors that F-18 NaF can accurately measure.
Eligibility:
- Men at least 18 years of age who have been diagnosed with prostate cancer and have had imaging studies to determine whether the cancer has spread to their bones. Both patients with and without known bone involvement will be enrolled.
Design:
- Participants will be screened with a physical examination, medical history, and imaging studies, and will provide baseline blood samples to evaluate kidney function.
- For the study, participants will have two F-18 NaF PET/CT scans on separate days for baseline. These repeat scans will be used to determine the amount of change that is due to the imaging process alone (i.e. not due to the disease getting better or worse. Participants will receive a dose of F-18 NaF intravenously, and will have PET/CT scanning over the body (mid ear to upper thighs) over 1 hour, the body followed by a complete whole-body PET/CT scan at approximately 2 hours after F-18 NaF injection. Participants will be watched closely for side effects from the F-18 NaF until the scans are done, and will be asked to drink plenty of water to void the F-18 NaF from the body after the scans.
- As a followup study, participants will have two more F-18 NaF PET/CT scans, one 4 to 8 months after the first scans and then one 10 to 14 months after the first scans. Participants will provide additional blood samples before the followup scans.
Detailed description
Background:
- Evaluating response to therapy in prostate cancer is limited by the inability to quantify bony metastatic disease
- F-18 sodium fluoride (NaF) is a PET radiopharmaceutical which localizes in regions of bony turnover, and was the 1st bone scan agents (prior to Tc-99m MDP (methylene diphosphonate) availability)
- Today s high sensitivity PET cameras can image the distribution of F-18 NaF as a whole body volume and permit quantification of uptake over time. The addition of co-registered CT increases the diagnostic accuracy for detection of metastatic disease
Primary Objective:
-To evaluate the feasibility of using NaF PET/CT to quantitatively measure the extent of bony metastatic disease in patients with prostate cancer in patients
- To determine the intra-patient reproducibility of F-18 NaF PET/CT
- To explore the relationship between the biodistribution changes in F-18 NaF PET/CT parameters and the clinical response
Eligibility:
- Participant must have pathology proven adenocarcinoma of the prostate.
- Participant must have
- A history of PSA > 10ng/mL or a history of PSA doubling time of less than or equal to 6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP bone scan, CT etc).
OR
--Any PSA (prostate specific antigen) level and known bone metastatic disease on standard of care imaging (Tc-99m MDP bone scan, CT etc.)
- Participant must be 18 years or older and have ECOG (Eastern Cooperative Oncology Group) Performance grade of 0 to 2
- Ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Design:
This is a pilot, 2-arm, open label study of patients with prostate cancer. One arm will accrue patients with known bone metastases and the second will accrue patient at risk of developing bone metastases (30 patients per group; total enrollment 60 patients). As it is possible that there will be different rates of bone lesion detection dependent on hormone responsiveness of the tumors, further stratification (castrate sensitive vs. castrate resistant tumor) may be performed to evaluate for predominant trends. All participants will undergo a static F-18 NaF imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. The change in bone uptake of F-18 NaF will be measured, reproducibility determined, and preliminary comparisons with clinical response will be made.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mets via NaF-18 PET/CT | Active comparator | Drug: F-18 NaFPatients with known bone metastases (i.e. mets). |
| No-Mets via NaF-18 PET/CT | Active comparator | Drug: F-18 NaFPatients with no clinical evidence of bone metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have a clinical course consistent with prostate cancer and have available documentation of prostate adenocarcinoma from either the National Cancer Institute (NCI) or from an outside pathology laboratory.
- A history of PSA of > 10ng/mL or a history of PSA doubling time of less than or equal to 6 months, and no known bone metastatic involvement on standard of care imaging (Tc-99m MDP bone scan, CT etc)
- OR
- Any PSA level and known bone metastatic disease on standard of care imaging (Tc-99m MDP bone scan, CT etc).
- Ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Key exclusion criteria (3 listed)
- Participants with severe claustrophobia unresponsive to oral anxiolytics.
- Subjects weighing greater than 350 lbs (weight limit for scanner table), or unable to fit within the imaging gantry.
- Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study.
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 |
|---|---|---|
| F-18 NaFAll participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. | Drug | Mets via NaF-18 PET/CT, No-Mets via NaF-18 PET/CT |
Primary outcome
Number of Participants With Present or Not Present Bone Metastasis
Time frame: Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.
Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: date treatment consent signed to date off study, approximately 52.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18309951Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.
- Background: PubMed 15470213Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
- Background: PubMed 18077529Grant FD, Fahey FH, Packard AB, Davis RT, Alavi A, Treves ST. Skeletal PET with 18F-fluoride: applying new technology to an old tracer. J Nucl Med. 2008 Jan;49(1):68-78. doi: 10.2967/jnumed.106.037200. Epub 2007 Dec 12.
- Results publication: PubMed 22728263Kurdziel KA, Shih JH, Apolo AB, Lindenberg L, Mena E, McKinney YY, Adler SS, Turkbey B, Dahut W, Gulley JL, Madan RA, Landgren O, Choyke PL. The kinetics and reproducibility of 18F-sodium fluoride for oncology using current PET camera technology. J Nucl Med. 2012 Aug;53(8):1175-84. doi: 10.2967/jnumed.111.100883. Epub 2012 Jun 22.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized patient images and associated Prostate Specific-Antigen (PSA) and Gleason Scores.
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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.
Karen A Kurdziel, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F-18 NaF in people with Prostate Neoplasm, run by National Cancer Institute (NCI) 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 6 inclusion and 3 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 6 Nov 2017. 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.
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 24 Dec 2014). 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?
Number of Participants With Present or Not Present Bone Metastasis (time frame: Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240551, which also lists 4 linked publications.
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 6 Nov 2017.