Prostate CancerNCT05041504
A Web-based Peer Navigation Program for Men With Prostate Cancer
A study testing Peer navigation in people with Prostate Cancer, run by University Health Network, Toronto at 3 sites in Canada.
Trial summary
One in nine Canadian men will be diagnosed with prostate cancer (PC) in their lifetime. Although all treatment options can be effective in controlling the disease, treatment side effects such as problems with erections and controlling the bladder can significantly affect men's quality of life. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Peer navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesCanada
- Study dates
- 13 May 2022to 1 Dec 2024
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has been diagnosed with local, locally advanced or stable metastatic PC.
- Has recently completed treatment within 3 months
- Has an email address OR is willing to create one.
- Can read and speak English.
Who cannot join
- Has been diagnosed with advanced metastatic disease.
- Is receiving palliative care.
- Is not willing to be randomized.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Web-based Peer Navigation Program for Men With Prostate Cancer: A Hybrid Effectiveness-Implementation Trial
One in nine Canadian men will be diagnosed with prostate cancer (PC) in their lifetime. Although all treatment options can be effective in controlling the disease, treatment side effects such as problems with erections and controlling the bladder can significantly affect men's quality of life. Many men with PC say they do not get relevant information and emotional support, and experience gaps in care when dealing with these difficult issues. Previous studies have shown that cancer patient navigation improves access to care and support, and reduces healthcare costs. The investigators developed True North Peer Navigation - a peer navigation program for men with PC and a peer navigator training course. Men are matched online with a trained peer navigator who provides practical information and emotional support through the cancer journey. A pilot evaluation showed that it is highly acceptable to patients and peer navigators, and improves patient quality of life, social support and ability to manage their health. In this study, the investigators will conduct a randomized controlled trial of the True North Peer Navigation program in cancer centres in Ontario, British Columbia and Nova Scotia. Patients will be randomly assigned to receive True North Peer Navigation or an active wait list control consisting of usual care with access to information on the True North Peer Navigation website. The investigators will evaluate the effect of the True North Peer Navigation program on patient outcomes such as their ability to take a more active role in their health, quality of life, social support and use of health care services. In addition, the investigators will evaluate how True North Peer Navigation was implemented, the experiences patients and peer navigators, the factors that make it easier or harder for people to deliver the program to patients in different settings, as well as the cost of delivering the program, which will help us learn how to spread the program across the country.
Read the detailed description
Background: Prostate cancer (PC) is a highly prevalent condition affecting 1 in 9 Canadian men. While the 5-year survival rate for PC is 93%, treatment-related side effects, such as sexual dysfunction and urinary incontinence, can significantly affect quality of life. Men with PC lack access to relevant information and emotional support, and report gaps in supportive care when dealing with these difficult issues. Previous research has shown that cancer patient navigation improves the timeliness of care and support, and reduces healthcare costs. Engaging volunteer cancer survivors as navigators is less costly, provides peer support, and benefits the navigator by improving their psychosocial health. The investigators developed True North Peer Navigation - an evidence-based peer navigation program for men with PC and a competency-based peer navigator training course. Men are matched online with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. A pilot study showed True North Peer Navigation is highly acceptable to patients and peer navigators, and associated with improvements in quality of life, social support and patient activation to manage health.
Aim: This project aims to advance knowledge on the effectiveness and implementation of a web-based peer navigation program for men after treatment for PC.
Specific Objectives:
- To determine the effect of True North Peer Navigation on patient outcomes in men with PC; and
- To evaluate the delivery of True North Peer Navigation in terms of fidelity, cost, and the experiences of patients and peer navigators, and to identify barriers and facilitators to its implementation in oncology settings.
Methods: Guided by the SPOR Patient Engagement Framework, the investigators will conduct a type-1 hybrid effectiveness-implementation study at cancer centres in Ontario, British Columbia and Nova Scotia. For objective 1, the investigators will conduct a pragmatic randomized controlled trial to evaluate the impact of True North Peer Navigation compared to an active wait list control on patient activation (primary) and needs, quality of life, anxiety, depression, fear of recurrence, social support, and access to services (secondary). One hundred and fifty-two patients (n=76 per arm) with PC will be recruited after treatment. Outcomes will be assessed at baseline (T0), 3-months (T1) and 6-months (T2). Objective 2 will involve a mixed-method process evaluation to investigate implementation fidelity, patient and navigator experiences, and cost-effectiveness of True North Peer Navigation, and to assess implementation barriers and facilitators with stakeholders informed by the Consolidated Framework for Implementation Research and the Theoretical Domains Framework.
Significance: True North Peer Navigation is an innovative solution to an important service gap in the lives of men with PC. This study has the potential to generate important evidence and strategies to support the implementation of peer navigation programs to improve the health outcomes of men with PC in Canada.
Note: The planned sample size described in the grant was 152 participants, considering an expected 35% dropout rate, and recruitment from three sites (PM, BC-Cancer and QEII). After the grant was awarded, we added two recruitment sites (VGH and Cape Breton Regional Hospital). As a result, the sample size was increased to 240 participants (also considering a 35% dropout rate) to address the expected increase in heterogeneity as recommended for pragmatic trials. However, recruitment at these sites was not possible due to insufficient clinical champion support. Hence, we reverted to our original planned sample size and ceased recruitment when it was reached.
- Conditions
- Prostate Cancer
- Being tested
- Peer navigation, Active wait list control
- Keywords
- prostate cancer, navigation, peer support, web-based, patient activation
- Medical subject headings
- Prostatic Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer navigationBehavioural
Also called True North Peer Navigation
Participants in the intervention group will receive ongoing support from a trained peer navigator for 3 months after completing treatment for prostate cancer via the True North Peer Navigation website. Participants will be matched with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. Participants will also have access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer.
Active wait list controlOther
Also called Web-based educational wait list control
Participants in the active wait list control group will receive usual care and access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer. After completion of the study, patients in the active wait list control group will be matched with a peer navigator.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants assigned to the intervention arm will receive the True North Peer Navigation intervention. Receives: Behavioral: Peer navigation |
| Active Waitlist Control | Other | Participants assigned to the control arm will receive usual care and access to an online health resource library. After completion of the study, they will receive the True North Peer Navigation intervention. Receives: Other: Active wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation at 3 months
The primary outcome will be Patient Activation at 3 months. Patient Activation will be measured using the Patient Activation Measure (PAM). Higher scores represent a better outcome.
Measured: 0, 3 months
Secondary outcomes (8)
Patient Activation at 6 months
Patient Activation at 6 months will be assessed. Patient Activation will be measured using the Patient Activation Measure (PAM). Higher scores represent a better outcome.
Measured: 0, 6 months
Supportive Care Needs
Supportive Care Needs will be assessed at 3 months and 6 months separately. Supportive Care Needs will be measured with the 34-item Supportive Care Needs Survey-Short Form (SCNS-SF). Higher scores represent a worse outcome.
Measured: 0, 3, 6 months
Health-Related Quality of Life
Health-related quality of life will be assessed at 3 months and 6 months separately. Health-related quality of life will be measured with the European Quality of Life, 5 Dimensions, 5 Levels (EQ-5D-5L) overall utility score. Higher scores represent a better outcome.
Measured: 0, 3, 6 months
Prostate Cancer Quality of Life
Prostate Cancer Specific Quality of Life will be measured at 3 months and 6 months separately. Prostate Cancer Specific Quality of Life will be measured using the overall Patient-Oriented Prostate Utility Scale (PORPUS) score. Higher scores represent a better outcome.
Measured: 0, 3, 6 months
Anxiety
Anxiety will be assessed at 3 months and 6 months separately. Anxiety will be measured using the Generalized Anxiety Disorder scale (GAD-7). Higher scores represent a worse outcome.
Measured: 0, 3, 6 months
Depression
Depression will be assessed at 3 months and 6 months separately. Depression will be measured using the depression module of the Patient Health Questionnaire (PHQ-9). Higher scores represent a worse outcome.
Measured: 0, 3, 6 months
Social Support
Social Support will be assessed at 3 months and 6 months separately. Social Support will be measured using the Enriched Social Support Scale, a multidimensional measure of perceived social support (ESSI). Higher scores represent a better outcome.
Measured: 0, 3, 6 months
Fear of Cancer Recurrence
Fear of Cancer Recurrence will be assessed at 3 months and 6 months separately. Fear of Cancer Recurrence will be measured using the Fear of Cancer Recurrence Inventory -Short Form Scale (FCRI-SF). Higher scores represent a worse outcome.
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start13 May 2022
- Primary completion18 Mar 2024
- Study completion1 Dec 2024
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 University Health Network, TorontoThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 2-arm pragmatic randomized controlled trial with an active wait-list control, and an embedded process evaluation. Participants in the intervention group will receive the True North Peer Navigation intervention. Participants in the active control group will receive access to an online health resource library and will be offered the True North Peer Navigation intervention after study completion.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Dalhousie University, University of Toronto, Canadian Cancer Society (CCS), Canadian Partnership Against Cancer, Movember Foundation, Walnut Foundation, Prostate Cancer Support - Toronto, Prostate Cancer Group - Burnaby
- Responsible party
- Sponsor
- Investigators
- Jackie Bender, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041504
- Sponsor's protocol ID
- 21-5126
- Other IDs
- Peer Navigation pRCT
- Status last verified
- Jan 2026
- First submitted
- 10 Aug 2021
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bender JL, Flora PK, Milosevic E, Soheilipour S, Maharaj N, Dirlea M, Parvin L, Matthew A, Kazanjian A. Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. Support Care Cancer. 2021 Mar;29(3):1235-1244. doi: 10.1007/s00520-020-05586-8. Epub 2020 Jul 2.
PubMed 32613373Flora PK, Bender JL, Miller AS, Parvin L, Soheilipour S, Maharaj N, Milosevic E, Matthew A, Kazanjian A. A core competency framework for prostate cancer peer navigation. Support Care Cancer. 2020 Jun;28(6):2605-2614. doi: 10.1007/s00520-019-05059-7. Epub 2019 Oct 15.
PubMed 31616997Maharaj N, Soheilipour S, Bender JL, Kazanjian A. Understanding Prostate Cancer Patients and Caregivers Support Needs: How Do They Manage Living with Cancer? Illness, Crisis & Loss. 2018; April 5:51-73.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Peer Navigation Program for Men With Prostate Cancer: A Hybrid Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT05041504
- Acronym / sponsor ID
- 21-5126
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, navigation, peer support, web-based, patient activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of British Columbia, Dalhousie University, University of Toronto, Canadian Cancer Society (CCS), Canadian Partnership Against Cancer, Movember Foundation, Walnut Foundation, Prostate Cancer Support - Toronto, Prostate Cancer Group - Burnaby
- Study start
- 13 May 2022 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Sep 2021 (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.
One in nine Canadian men will be diagnosed with prostate cancer (PC) in their lifetime. Although all treatment options can be effective in controlling the disease, treatment side effects such as problems with erections and controlling the bladder can significantly affect men's quality of life. Many men with PC say they do not get relevant information and emotional support, and experience gaps in care when dealing with these difficult issues. Previous studies have shown that cancer patient navigation improves access to care and support, and reduces healthcare costs. The investigators developed True North Peer Navigation - a peer navigation program for men with PC and a peer navigator training course. Men are matched online with a trained peer navigator who provides practical information and emotional support through the cancer journey. A pilot evaluation showed that it is highly acceptable to patients and peer navigators, and improves patient quality of life, social support and ability to manage their health. In this study, the investigators will conduct a randomized controlled trial of the True North Peer Navigation program in cancer centres in Ontario, British Columbia and Nova Scotia. Patients will be randomly assigned to receive True North Peer Navigation or an active wait list control consisting of usual care with access to information on the True North Peer Navigation website. The investigators will evaluate the effect of the True North Peer Navigation program on patient outcomes such as their ability to take a more active role in their health, quality of life, social support and use of health care services. In addition, the investigators will evaluate how True North Peer Navigation was implemented, the experiences patients and peer navigators, the factors that make it easier or harder for people to deliver the program to patients in different settings, as well as the cost of delivering the program, which will help us learn how to spread the program across the country.
Detailed description
Background: Prostate cancer (PC) is a highly prevalent condition affecting 1 in 9 Canadian men. While the 5-year survival rate for PC is 93%, treatment-related side effects, such as sexual dysfunction and urinary incontinence, can significantly affect quality of life. Men with PC lack access to relevant information and emotional support, and report gaps in supportive care when dealing with these difficult issues. Previous research has shown that cancer patient navigation improves the timeliness of care and support, and reduces healthcare costs. Engaging volunteer cancer survivors as navigators is less costly, provides peer support, and benefits the navigator by improving their psychosocial health. The investigators developed True North Peer Navigation - an evidence-based peer navigation program for men with PC and a competency-based peer navigator training course. Men are matched online with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. A pilot study showed True North Peer Navigation is highly acceptable to patients and peer navigators, and associated with improvements in quality of life, social support and patient activation to manage health.
Aim: This project aims to advance knowledge on the effectiveness and implementation of a web-based peer navigation program for men after treatment for PC.
Specific Objectives:
- To determine the effect of True North Peer Navigation on patient outcomes in men with PC; and
- To evaluate the delivery of True North Peer Navigation in terms of fidelity, cost, and the experiences of patients and peer navigators, and to identify barriers and facilitators to its implementation in oncology settings.
Methods: Guided by the SPOR Patient Engagement Framework, the investigators will conduct a type-1 hybrid effectiveness-implementation study at cancer centres in Ontario, British Columbia and Nova Scotia. For objective 1, the investigators will conduct a pragmatic randomized controlled trial to evaluate the impact of True North Peer Navigation compared to an active wait list control on patient activation (primary) and needs, quality of life, anxiety, depression, fear of recurrence, social support, and access to services (secondary). One hundred and fifty-two patients (n=76 per arm) with PC will be recruited after treatment. Outcomes will be assessed at baseline (T0), 3-months (T1) and 6-months (T2). Objective 2 will involve a mixed-method process evaluation to investigate implementation fidelity, patient and navigator experiences, and cost-effectiveness of True North Peer Navigation, and to assess implementation barriers and facilitators with stakeholders informed by the Consolidated Framework for Implementation Research and the Theoretical Domains Framework.
Significance: True North Peer Navigation is an innovative solution to an important service gap in the lives of men with PC. This study has the potential to generate important evidence and strategies to support the implementation of peer navigation programs to improve the health outcomes of men with PC in Canada.
Note: The planned sample size described in the grant was 152 participants, considering an expected 35% dropout rate, and recruitment from three sites (PM, BC-Cancer and QEII). After the grant was awarded, we added two recruitment sites (VGH and Cape Breton Regional Hospital). As a result, the sample size was increased to 240 participants (also considering a 35% dropout rate) to address the expected increase in heterogeneity as recommended for pragmatic trials. However, recruitment at these sites was not possible due to insufficient clinical champion support. Hence, we reverted to our original planned sample size and ceased recruitment when it was reached.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a 2-arm pragmatic randomized controlled trial with an active wait-list control, and an embedded process evaluation. Participants in the intervention group will receive the True North Peer Navigation intervention. Participants in the active control group will receive access to an online health resource library and will be offered the True North Peer Navigation intervention after study completion.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Peer navigationParticipants assigned to the intervention arm will receive the True North Peer Navigation intervention. |
| Active Waitlist Control | Other | Other: Active wait list controlParticipants assigned to the control arm will receive usual care and access to an online health resource library. After completion of the study, they will receive the True North Peer Navigation intervention. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Has been diagnosed with local, locally advanced or stable metastatic PC.
- Has recently completed treatment within 3 months
- Has an email address OR is willing to create one.
- Can read and speak English.
Key exclusion criteria (3 listed)
- Has been diagnosed with advanced metastatic disease.
- Is receiving palliative care.
- Is not willing to be randomized.
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 |
|---|---|---|
| Peer navigationAlso: True North Peer NavigationParticipants in the intervention group will receive ongoing support from a trained peer navigator for 3 months after completing treatment for prostate cancer via the True North Peer Navigation website. Participants will be matched with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. Participants will also have access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer. | Behavioural | Intervention |
| Active wait list controlAlso: Web-based educational wait list controlParticipants in the active wait list control group will receive usual care and access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer. After completion of the study, patients in the active wait list control group will be matched with a peer navigator. | Other | Active Waitlist Control |
Primary outcome
Patient Activation at 3 months
Time frame: 0, 3 months
The primary outcome will be Patient Activation at 3 months. Patient Activation will be measured using the Patient Activation Measure (PAM). Higher scores represent a better outcome.
8 secondary outcomes
Patient Activation at 6 months
Time frame: 0, 6 months
Supportive Care Needs
Time frame: 0, 3, 6 months
Health-Related Quality of Life
Time frame: 0, 3, 6 months
Prostate Cancer Quality of Life
Time frame: 0, 3, 6 months
Anxiety
Time frame: 0, 3, 6 months
Depression
Time frame: 0, 3, 6 months
Social Support
Time frame: 0, 3, 6 months
Fear of Cancer Recurrence
Time frame: 0, 3, 6 months
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 9 Jan 2026.
- Background: PubMed 32613373Bender JL, Flora PK, Milosevic E, Soheilipour S, Maharaj N, Dirlea M, Parvin L, Matthew A, Kazanjian A. Training prostate cancer survivors and caregivers to be peer navigators: a blended online/in-person competency-based training program. Support Care Cancer. 2021 Mar;29(3):1235-1244. doi: 10.1007/s00520-020-05586-8. Epub 2020 Jul 2.
- Background: PubMed 31616997Flora PK, Bender JL, Miller AS, Parvin L, Soheilipour S, Maharaj N, Milosevic E, Matthew A, Kazanjian A. A core competency framework for prostate cancer peer navigation. Support Care Cancer. 2020 Jun;28(6):2605-2614. doi: 10.1007/s00520-019-05059-7. Epub 2019 Oct 15.
- BackgroundMaharaj N, Soheilipour S, Bender JL, Kazanjian A. Understanding Prostate Cancer Patients and Caregivers Support Needs: How Do They Manage Living with Cancer? Illness, Crisis & Loss. 2018; April 5:51-73.
- TrueNORTH Peer Navigation intervention websiteLink provided by the sponsor.
- 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.
Jackie Bender, PhD principal investigator
University Health Network, Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer navigation in people with Prostate Cancer, run by University Health Network, Toronto at 3 sites 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 4 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 9 Jan 2026. 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 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.
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?
Patient Activation at 3 months (time frame: 0, 3 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 NCT05041504, 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 9 Jan 2026.