Prostate CancerPhase 3NCT02692105
Comparison of HDR vs. LDR Brachytherapy as Monotherapy for Intermediate Risk Prostate Cancer
A Phase 3 study testing Low dose rate prostate brachytherapy and High Dose Rate prostate brachytherapy in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
This study will offer men with intermediate risk prostate cancer who are suitable for, and interested in, prostate brachytherapy, the opportunity to be randomized between low dose rate (LDR) brachytherapy using permanent implantation of radioactive seeds (the current standard of care in BC) and high dose rate (HDR) or… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Low dose rate prostate brachytherapy and High Dose Rate prostate brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical stage T1c-T2b, PSA < 20, Gleason < 8
- ECOG 0-1
- Low tier intermediate-risk prostate cancer is defined by;
- o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA < 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml)
- Extensive favorable-risk disease is defined as:
- clinical stage T1c-T2a
Show all 20Show fewer
- PSA < 10
- Gleason 6
- ≥ 50% of biopsy cores containing cancer
- PSA density > 0.2 ng/cc
- Selected intermediate risk patients not defined above
- - T1c/T2a
- - PSA < 10
- -Gleason 4+3
- -< 33% of cores involved
- -Max tumour length in any core 10 mm
- No androgen deprivation therapy (ADT)
- Prostate volume by TRUS ≤ 60 cc.
- Not eligible for, or accepting of, active surveillance according to NCCN guidelines.
- Signed study specific informed consent.
Who cannot join
- Prior radical surgery for carcinoma of the prostate,
- Prior pelvic radiation
- Prior chemotherapy for prostate cancer,
- Prior TURP or cryosurgery of the prostate
- Claustrophobic or unable to undergo MRI
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Cancer Agency Center for the Southern Interior
Kelowna, British Columbia, V1Y5L3
About this study
Official title: A Phase III Randomized Pilot Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favourable Risk and Low Tier Intermediate Risk Prostate Cancer
This study will offer men with intermediate risk prostate cancer who are suitable for, and interested in, prostate brachytherapy, the opportunity to be randomized between low dose rate (LDR) brachytherapy using permanent implantation of radioactive seeds (the current standard of care in BC) and high dose rate (HDR) or temporary brachytherapy which is also available as a standard of care in BC but only when used as a boost in addition with external beam radiotherapy. In addition, men will be offered the opportunity for testing the aggressiveness of their cancer using Cell Cycle Progression Gene Profile.
Read the detailed description
Purpose:
To conduct a Phase III randomized trial for favorable tier intermediate risk prostate cancer and selected favorable risk tumors to evaluate the difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
Hypothesis:
Because of more rapid dose delivery with HDR compared to LDR brachytherapy (15 minutes vs. 6 months) and more precise control of dose to adjacent critical structures (prostatic and bulbo-membranous urethra and anterior rectal wall), HDR prostate brachytherapy has been associated with more rapid recovery from acute symptoms and a more favorable side effect protocol when used as a boost in combination with external beam radiotherapy. The hypothesis is that this advantage will be maintained when brachytherapy is used as monotherapy without the addition of external beam radiation.
Justification:
In British Columbia, LDR prostate brachytherapy is the current standard for selected men with favorable risk prostate cancer who are not suitable for, or willing to accept active surveillance, and for men with favorable intermediate risk prostate cancer. LDR brachytherapy has been available in BC for over 15 years and is highly effective with 7-year biochemical disease-free rates of ~95%. However, this type of treatment has a prolonged recovery phase with return to baseline urinary function taking 6 to 12 months. This is partly due to the fact that the radiation is delivered over a 6 month period from the implanted seeds, and partly due to uncertainty in final seed placement. HDR brachytherapy has the advantage of delivering treatment very rapidly over 15-20 minutes, and also exploits the radiobiologic nature of prostate cancer which is more responsive to large doses of radiotherapy. Experience with using HDR brachytherapy as a boost has shown a much reduced impact on quality of life.
Objectives:
Primary: To evaluate the difference in QOL in the urinary domain between LDR and HDR brachytherapy using the urinary domain of the EPIC prostate cancer specific QOL questionnaire.
Secondary:
- To assess differences in the bowel and sexual domains of the EPIC prostate cancer specific QOL questionnaire between the 2 treatments
- To asses time to recovery of the IPS Score which is widely used to assess urinary function after prostate cancer treatment. The time to return to baseline +/- 3 points will be determined.
- Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point
- TRUS- MRI fusion will be developed within our planning software to facilitate treatment planning
- To assess treatment efficacy, PSA will be recorded every 6 months to 5 years and then annually to 10 years and prostate re-biopsy will be performed at 36 months after radiotherapy.
Optional:
For those patients consenting to targeted biopsies under anaesthesia at the start of their brachytherapy procedure (separate consent)
- Verify MRI-TRUS fusion accuracy
- Correlate Cell Cycle Progression scores with outcome.
Research Method:
Multiparametric MRI (mpMRI)will be performed on all men as a staging procedure to ensure appropriateness for brachytherapy as monotherapy (without the addition of external beam radiotherapy or hormone therapy). The value of mpMRI in staging prostate cancer is widely recognized. Previous studies have shown that over 90% of intermediate risk cancers are visible on mpMRI. The MR images will be fused with the planning trans rectal ultrasound (TRUS) for each patient, ensuring adequate dose coverage of the lesion.
For those patients consenting to optional biopsies under anesthesia, accuracy of the fusion will be verified by obtaining 2 biopsies of the visualized lesion under TRUS guidance at the start of the brachytherapy procedure.
Follow up is as per standard practice to assess urinary, bowel and sexual side effects. In addition to the standard forms, patients will also complete an EPIC questionnaire. The questionnaires are completed every 3 months for 1 year and then every 6 months to 3 years and then annually, as per the standard follow up schedule.
Once the biopsy material has been pathologically confirmed to contain the target lesion, the aggressiveness will be assessed through Cell Cycle Progression (CCP) Gene Profile testing.
Men may be randomized to the type of brachytherapy and decline the biopsies. This initial protocol is a Pilot that will test feasibility of the randomization (patient acceptance). The aim is to accrue 60 men over 18-24 months and if achieved then apply to expand to a total of 200 men.
- Conditions
- Prostate Cancer
- Being tested
- Low dose rate prostate brachytherapy, High Dose Rate prostate brachytherapy
- Keywords
- prostate adenocarcinoma, intermediate risk group, brachytherapy, High Dose Rate vs Low Dose Rate, Quality of Life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose rate prostate brachytherapyRadiation
Also called LDR brachytherapy, seed brachytherapy
Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance
High Dose Rate prostate brachytherapyRadiation
Also called HDR brachytherapy
Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate
| Study group | Role | What they receive |
|---|---|---|
| Low dose rate brachytherapy | Active comparator | Device: Radiation Low dose rate prostate brachytherapy is delivered under anaesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality. Receives: Radiation: Low dose rate prostate brachytherapy |
| High dose rate brachytherapy | Experimental | Device: Radiation High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anaesthesia, but no follow-up imaging visit is required.
HDR brachytherapy is also accomplished as an out-patient. Receives: Radiation: High Dose Rate prostate brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.
Measured: 0-36 months
Secondary outcomes (7)
Quality of Life in the bowel and sexual domains
The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24 and 36 months
Measured: 0-36 months
Time to return to baseline +/- 3 points for the International Prostate Symptom Score
The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24 and 36 months
Measured: 0-36 months
Acute and long term toxicity
Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point
Measured: 0-10 years
TRUS- MRI fusion
TRUS- MRI fusion will be developed within our planning software to facilitate treatment planning
Measured: baseline
Biochemical Outcome
PSA will be recorded every 6 months to 5 years and then annually to 10 years
Measured: 5-10 years
Histologic Outcome
Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment
Measured: 3 years
Cell cycle progression score
For those patients consenting to targeted biopsies under anesthesia at the start of their brachytherapy procedure (separate optional consent) MRI-TRUS fusion accuracy will be verified by targeted biopsies and Biopsy material will be sent for genetic testing to determine Cell cycle Progression scores for both arms of the trial to ultimately correlate with outcome.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2021
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juanita Crook, British Columbia Cancer Agency
- Investigators
- Ross Halperin, MD, Study director, British Columbia Cancer Agency Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692105
- Sponsor's protocol ID
- H15-02103
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2016
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Crook J, Ots A, Gaztanaga M, Schmid M, Araujo C, Hilts M, Batchelar D, Parker B, Bachand F, Milette MP. Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion. Brachytherapy. 2014 Sep-Oct;13(5):433-41. doi: 10.1016/j.brachy.2014.05.006. Epub 2014 Jun 20.
PubMed 24958556Batchelar D, Gaztanaga M, Schmid M, Araujo C, Bachand F, Crook J. Validation study of ultrasound-based high-dose-rate prostate brachytherapy planning compared with CT-based planning. Brachytherapy. 2014 Jan-Feb;13(1):75-9. doi: 10.1016/j.brachy.2013.08.004. Epub 2013 Sep 27.
PubMed 24080299Schmid M, Crook JM, Batchelar D, Araujo C, Petrik D, Kim D, Halperin R. A phantom study to assess accuracy of needle identification in real-time planning of ultrasound-guided high-dose-rate prostate implants. Brachytherapy. 2013 Jan-Feb;12(1):56-64. doi: 10.1016/j.brachy.2012.03.002. Epub 2012 Apr 17.
PubMed 22513104
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Pilot Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favourable Risk and Low Tier Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02692105
- Acronym / sponsor ID
- H15-02103
- Conditions
- Prostate Cancer
- Keywords
- prostate adenocarcinoma, intermediate risk group, brachytherapy, High Dose Rate vs Low Dose Rate, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- 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.
This study will offer men with intermediate risk prostate cancer who are suitable for, and interested in, prostate brachytherapy, the opportunity to be randomized between low dose rate (LDR) brachytherapy using permanent implantation of radioactive seeds (the current standard of care in BC) and high dose rate (HDR) or temporary brachytherapy which is also available as a standard of care in BC but only when used as a boost in addition with external beam radiotherapy. In addition, men will be offered the opportunity for testing the aggressiveness of their cancer using Cell Cycle Progression Gene Profile.
Detailed description
Purpose:
To conduct a Phase III randomized trial for favorable tier intermediate risk prostate cancer and selected favorable risk tumors to evaluate the difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
Hypothesis:
Because of more rapid dose delivery with HDR compared to LDR brachytherapy (15 minutes vs. 6 months) and more precise control of dose to adjacent critical structures (prostatic and bulbo-membranous urethra and anterior rectal wall), HDR prostate brachytherapy has been associated with more rapid recovery from acute symptoms and a more favorable side effect protocol when used as a boost in combination with external beam radiotherapy. The hypothesis is that this advantage will be maintained when brachytherapy is used as monotherapy without the addition of external beam radiation.
Justification:
In British Columbia, LDR prostate brachytherapy is the current standard for selected men with favorable risk prostate cancer who are not suitable for, or willing to accept active surveillance, and for men with favorable intermediate risk prostate cancer. LDR brachytherapy has been available in BC for over 15 years and is highly effective with 7-year biochemical disease-free rates of ~95%. However, this type of treatment has a prolonged recovery phase with return to baseline urinary function taking 6 to 12 months. This is partly due to the fact that the radiation is delivered over a 6 month period from the implanted seeds, and partly due to uncertainty in final seed placement. HDR brachytherapy has the advantage of delivering treatment very rapidly over 15-20 minutes, and also exploits the radiobiologic nature of prostate cancer which is more responsive to large doses of radiotherapy. Experience with using HDR brachytherapy as a boost has shown a much reduced impact on quality of life.
Objectives:
Primary: To evaluate the difference in QOL in the urinary domain between LDR and HDR brachytherapy using the urinary domain of the EPIC prostate cancer specific QOL questionnaire.
Secondary:
- To assess differences in the bowel and sexual domains of the EPIC prostate cancer specific QOL questionnaire between the 2 treatments
- To asses time to recovery of the IPS Score which is widely used to assess urinary function after prostate cancer treatment. The time to return to baseline +/- 3 points will be determined.
- Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point
- TRUS- MRI fusion will be developed within our planning software to facilitate treatment planning
- To assess treatment efficacy, PSA will be recorded every 6 months to 5 years and then annually to 10 years and prostate re-biopsy will be performed at 36 months after radiotherapy.
Optional:
For those patients consenting to targeted biopsies under anaesthesia at the start of their brachytherapy procedure (separate consent)
- Verify MRI-TRUS fusion accuracy
- Correlate Cell Cycle Progression scores with outcome.
Research Method:
Multiparametric MRI (mpMRI)will be performed on all men as a staging procedure to ensure appropriateness for brachytherapy as monotherapy (without the addition of external beam radiotherapy or hormone therapy). The value of mpMRI in staging prostate cancer is widely recognized. Previous studies have shown that over 90% of intermediate risk cancers are visible on mpMRI. The MR images will be fused with the planning trans rectal ultrasound (TRUS) for each patient, ensuring adequate dose coverage of the lesion.
For those patients consenting to optional biopsies under anesthesia, accuracy of the fusion will be verified by obtaining 2 biopsies of the visualized lesion under TRUS guidance at the start of the brachytherapy procedure.
Follow up is as per standard practice to assess urinary, bowel and sexual side effects. In addition to the standard forms, patients will also complete an EPIC questionnaire. The questionnaires are completed every 3 months for 1 year and then every 6 months to 3 years and then annually, as per the standard follow up schedule.
Once the biopsy material has been pathologically confirmed to contain the target lesion, the aggressiveness will be assessed through Cell Cycle Progression (CCP) Gene Profile testing.
Men may be randomized to the type of brachytherapy and decline the biopsies. This initial protocol is a Pilot that will test feasibility of the randomization (patient acceptance). The aim is to accrue 60 men over 18-24 months and if achieved then apply to expand to a total of 200 men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose rate brachytherapy | Active comparator | Radiation: Low dose rate prostate brachytherapyDevice: Radiation Low dose rate prostate brachytherapy is delivered under anaesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality. |
| High dose rate brachytherapy | Experimental | Radiation: High Dose Rate prostate brachytherapyDevice: Radiation High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anaesthesia, but no follow-up imaging visit is required. HDR brachytherapy is also accomplished as an out-patient. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Clinical stage T1c-T2b, PSA < 20, Gleason < 8
- ECOG 0-1
- Low tier intermediate-risk prostate cancer is defined by;
- o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA < 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml)
- Extensive favorable-risk disease is defined as:
Key exclusion criteria (5 listed)
- Prior radical surgery for carcinoma of the prostate,
- Prior pelvic radiation
- Prior chemotherapy for prostate cancer,
- Prior TURP or cryosurgery of the prostate
- Claustrophobic or unable to undergo MRI
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 |
|---|---|---|
| Low dose rate prostate brachytherapyAlso: LDR brachytherapy, seed brachytherapyPermanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance | Radiation | Low dose rate brachytherapy |
| High Dose Rate prostate brachytherapyAlso: HDR brachytherapyTemporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate | Radiation | High dose rate brachytherapy |
Primary outcome
The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
Time frame: 0-36 months
The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.
7 secondary outcomes
Quality of Life in the bowel and sexual domains
Time frame: 0-36 months
Time to return to baseline +/- 3 points for the International Prostate Symptom Score
Time frame: 0-36 months
Acute and long term toxicity
Time frame: 0-10 years
TRUS- MRI fusion
Time frame: baseline
Biochemical Outcome
Time frame: 5-10 years
Histologic Outcome
Time frame: 3 years
Cell cycle progression score
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 24958556Crook J, Ots A, Gaztanaga M, Schmid M, Araujo C, Hilts M, Batchelar D, Parker B, Bachand F, Milette MP. Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion. Brachytherapy. 2014 Sep-Oct;13(5):433-41. doi: 10.1016/j.brachy.2014.05.006. Epub 2014 Jun 20.
- Background: PubMed 24080299Batchelar D, Gaztanaga M, Schmid M, Araujo C, Bachand F, Crook J. Validation study of ultrasound-based high-dose-rate prostate brachytherapy planning compared with CT-based planning. Brachytherapy. 2014 Jan-Feb;13(1):75-9. doi: 10.1016/j.brachy.2013.08.004. Epub 2013 Sep 27.
- Background: PubMed 22513104Schmid M, Crook JM, Batchelar D, Araujo C, Petrik D, Kim D, Halperin R. A phantom study to assess accuracy of needle identification in real-time planning of ultrasound-guided high-dose-rate prostate implants. Brachytherapy. 2013 Jan-Feb;12(1):56-64. doi: 10.1016/j.brachy.2012.03.002. Epub 2012 Apr 17.
- Individual participant dataSharing planned: No
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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.
Ross Halperin, MD study director
British Columbia Cancer Agency Program Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low dose rate prostate brachytherapy and High Dose Rate prostate brachytherapy in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
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 20 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy. (time frame: 0-36 months). 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 NCT02692105, which also lists 3 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 29 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.