Prostate CancerPC-PEPNCT04895839
Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
A study testing Patient Empowerment Program in people with Prostate Cancer, run by Gabriela Ilie at 16 sites in 5 countries.
Trial summary
Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Patient Empowerment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,130 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 29 Sep 2021to 1 Oct 2031
- Phase
- Interventional
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18
- History of a prostate cancer diagnosis
- Safe to exercise and do strength training (participants who have recovered from a minor stroke or heart condition in the past will require approval from their Family Physician or Cardiologist to participate in the study. Participants with advanced prostate cancer will need approval from the Study Physician or their Urologist or Oncologist to participate)
- Existing (or willingness to create) email account
- Willingness to access and use daily email and/or text messages
- Ability to follow website links to watch YouTube videos
Show all 10Show fewer
- Ability to understand and speak English
- Ability to participate in low to moderate levels of physical activity
- Ability and willingness to fill out an online survey at baseline, and 6, 12 and 24 months, and a weekly compliance survey for the six months of the program.
- Deemed to have an expected survival greater than 2 years
Who cannot join
- Patients deemed unfit to participate in low level exercise eg. including but not limited to a myocardial infarction or stroke within the last year, without approval from their Family Physician or Cardiologist that they are safe to exercise.
- Unable to access the internet and lack of a computer or cellphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video.
- Men with a predicted survival less than 2 years.
Trial locations and contacts
16 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 5 countries
Canada11 sites, 11 recruiting
- Recruiting
Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, C1A 8T5
Larry Pan, MD, (902) 894-2951, lmpan@ihis.org
- Recruiting
Dianne and Irving Kipnes Urology Centre
Edmonton, Alberta, T6G 1Z1
Howard Evans, MD, 780-423-6843, howarde@ualberta.ca
Howard Evans, MD
- Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Gabriela Ilie, PhD, Gabriela.Ilie@dal.ca
- Recruiting
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna, British Columbia, V1Y 5L3
Susan Ellard, MD, SEllard@bccancer.bc.ca
- Recruiting
Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
François Bachand, MD, (819) 821-8000, Francois.Bachand.med@ssss.gouv.qc.ca
- Recruiting
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L4
Robert Thompson, MD, Robertd.thompson@horizonnb.ca
- Recruiting
Saskatoon Health Authority
Saskatoon, Saskatchewan, S7M 2W2
Kunal Jana, MD, Kunal.Jana@saskhealthauthority.ca
- Recruiting
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6
John Thoms, MD, (709) 777-2440, john.thoms@easternhealth.ca
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Christopher Wallis, MD, Christopher.Wallis@sinaihealth.ca
- Recruiting
Whitby Health Centre - Dr. Ernest Chan Medicine Professional Corporation
Whitby, Ontario, L1P 0P9
Ernest Chan, MD, (905) 721-3278, echan@lh.ca
- Recruiting
Men's Health Clinic Manitoba
Winnipeg, Manitoba, R3K 1M3
Jasmir Nayak, MD, (204) 221-4476, jnayak@sbgh.mb.ca
South Africa2 sites, 2 recruiting
- Recruiting
Sefako Makgatho Health University
Ga-Rankuwa, Gauteng, 2193
Shingai Mutambirwa, 27 12-5215632, shingai.mutambirwa@smu.ac.za
Shingai Mutambirwa, MD
- Recruiting
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2193
Duvern Ramiah, MD,MBA, 27 114812137, duvern.ramiah@wits.ac.za
Duvern Ramiah, MD
Belgium1 site, 1 recruiting
- Not yet recruiting
University Hospital Ghent
Ghent, East Flanders, 9000
Renée Bultijnck, PhD, +32 9 332 03 42, Renee.Bultijnck@UGent.be
New Zealand1 site, 1 recruiting
- Recruiting
Prostate Cancer Foundation of New Zealand
Auckland, 0632
Peter Dickens, peter.dickens@prostate.org.nz
Romania1 site, 1 recruiting
- Not yet recruiting
Medisprof Cancer Center
Cluj-Napoca, Transylvania, 400124
Adrian Udrea, MD, +40 0264705150, adrianudrea@medisprof.ro
About this study
Official title: PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. However, they typically incur both short- and long-term side effects (e.g. urinary incontinence, sexual dysfunction, reduced physical function, etc) that can negatively impact one's quality of life. This program of research aims to address the most critical needs of PC survivors: the development and evaluation of interventions to address the quality of life impact of PC. This study will test the Prostate Cancer Patient Empowerment Program (PC-PEP) in 400 men, a comprehensive intervention aimed at educating and teaching the men life skills/habits in order to improve their mental health issues, fitness levels and overall quality of life, and to decrease treatment related side effects. The program also aims to improve the overall health of the participants in the long term.
Read the detailed description
In a survey study of almost 400 survivors of prostate cancer (PC), the investigators found that 17% of them suffered currently from mental health issues, and most were not on medication to address this issue. Compounding issues included urinary and sexual disfunction, poor attendance to support groups, intimacy, problems sleeping and other health problems. To address these many issues directly, with the endorsement of physicians and patients attending our regional PC integrative care conference (April 2018) and expanding on pre-habitation (pre-surgery) science, the investigators created a Patient Empowerment Program (PEP) to be delivered from day one of diagnosis, to educate and teach the men and partners life skills/habits which are aimed to improve their fitness levels and quality of life, and to decrease treatment related side effects. This program is in line with the Auditor General of Nova Scotia's 2017 report endorsing the use of bottom-up evidence-based interventions, created from actively engaging patients in development and process. The investigators aim to trial PC-PEP for men undergoing curative treatment for PC versus a control group receiving standard care. The PC-PEP program includes in-person and multimedia informational, physical activity, pelvic floor, stress reduction, and relationship/connection training. The men are connected with other participants to increase social support and maximize compliance. Technology is used to deliver daily alerts to patients to remind them to engage in the program. A PC-PEP feasibility study of 30 men, over 28 days, showed that the program is feasible, leads to positive outcomes in patients and is highly (9.79/10) endorsed by patients. It is predicted that PC-PEP will improve mental health (primary outcome) and other quality of life outcomes of patients compared with 'usual care'.
A randomized, wait-list controlled clinical trial for men newly diagnosed with PC is currently underway. This next phase will open the program to more men and expand the inclusion criteria. Participants in the PC-PEP will receive the intervention for six months. Introducing a comprehensive empowerment program from day one of diagnosis may mitigate against the high levels of mental distress, short and long-term, suffered by hundreds of Nova Scotian men undergoing curative PC treatment every year, and the burden that treatment related side effects will place on our health care system. Given that the study has the endorsement of patients, clinicians and administrators at Nova Scotia Health, if proven successful it will have the evidence base needed to change the current standard of care.
- Conditions
- Prostate Cancer
- Being tested
- Patient Empowerment Program
- Keywords
- mental health, quality of life, empowerment program
- Medical subject headings
- Prostatic Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Empowerment ProgramBehavioural
The 6 months "at home" program focuses on aerobic and strength training, pelvic floor muscle exercises, meditation, social connection, and overall healthy lifestyle practices supported with daily text message/email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily and will be individualized to each participant. Pelvic floor muscle training will include three, 10-minute sessions and mediation for 10 minutes daily. Intimacy and Connection component of PC-PEP consists of engaging in at least one form of intimacy practice prescribed, per day. Social connection will be fostered by pairing participants up with peers from the study. To encourage program compliance, study participants will receive 3 daily reminders to do their pelvic floor muscle exercises per day plus an additional motivational email daily containing helpful tips.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Behavioral: Patient Empowerment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health
Kessler 10 - assessment of psychological distress. Measured through on-line survey.
Measured: 6 - 24 months
Secondary outcomes (10)
General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12)
The scale has a score range of 0 to 100, with a higher score indicating a better outcome, and a score of 50 indicating the U.S. population average.
Measured: 6 - 24 months
Disease Specific Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
A 39-item questionnaire. The scale has a total score range of 0-156 with a higher score indicating better quality of life.
Measured: 6 - 24 months
Urinary, Bowel, Hormonal, and Sexual Function as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
A 50-item questionnaire to evaluate patient function and bother after prostate cancer treatment. The scale has a score range of 0-100 with a higher score indicating a better outcome.
Measured: 6 - 24 months
Urinary Bother as assessed by the International Prostate Symptom Score (IPSS)
A 7-item questionnaire. The scale has a score range of 0-35 with a higher score indicating more severe urinary bother.
Measured: 6 - 24 months
Health Care Utilization
This will be assessed through the following survey questions:
- During the PAST 6 MONTHS, how many TIMES did you visit a doctor or health care provider for physical illness? (do not include visits while you were in the hospital for your Prostate Cancer treatment (e.g., radiation, surgery, etc)?
- During the PAST 6 MONTHS, how many TIMES did you visit a doctor or health care provider for a mental health issue?
- How many TIMES did you visit the emergency room in the PAST 6 MONTHS but were not admitted overnight?
- How many TIMES were you admitted to the hospital overnight in the PAST 6 MONTHS?
Measured: 6 - 24 months
Relationship Satisfaction as assessed by the Dyadic Adjustment Scale (DAS)
DAS is a 32-item questionnaire that measures an individual's perceptions of their relationship with an intimate partner. The scale has a total score range of 1-151 with a higher score indicating better satisfaction.
Measured: 6 - 24 months
Diet as assessed by the Starting the Conversation (STC) Questionnaire
STC is an 8-item simplified food frequency instrument designed for use in primary care and health-promotion settings. The instrument has a score range of 0-16 with a higher score indicating worse diet.
Measured: 6 - 24 months
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
PSQI included 19self-rated items that assess sleep quality and disturbances over a 1-month time interval. The scale has a score range of 0-21, with a higher score indicating worse sleep quality.
Measured: 6 - 24 months
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease 6-item Scale)
Change in SEMCD-6 total score. Scores range 1-10; higher scores indicate greater self-efficacy.
Measured: Baseline to 6 months; baseline to 12 months; baseline to 24 months.
Change in generalized anxiety symptoms (GAD-7)
Change in GAD-7 total score. Scores range 0-21; higher scores indicate greater anxiety.
Measured: Baseline to 6 months; Baseline to 12 months, Baseline to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start29 Sep 2021
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gabriela Ilie
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor-investigator, Gabriela Ilie, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895839
- Sponsor's protocol ID
- PC_PEP_Phase 4_Protocol
- Acronym
- PC-PEP
- Status last verified
- Mar 2026
- First submitted
- 13 May 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Okedara O, Ilie G, Brodovsky M, Mason RJ, Rendon R, Kokorovic A, Bailly G, Evans H, Jana K, Nayak JG, Chan E, Flax S, Patil N, Bowes D, Ramiah D, Mutambirwa S, Oberholzer A, Riley L, Cole J, Carruthers W, Taylar S, Rutledge RDH. From Availability to Access: A Mixed-Methods Study of Digital Prostate Cancer Survivorship Support for Black Men. Curr Oncol. 2026 Sep 9;33(9):543. doi: 10.3390/curroncol33090543.
PubMed 42782888
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
- ClinicalTrials.gov ID
- NCT04895839
- Acronym / sponsor ID
- PC-PEP / PC_PEP_Phase 4_Protocol
- Conditions
- Prostate Cancer
- Keywords
- mental health, quality of life, empowerment program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,130 participants (estimated)
- Lead sponsor
- Gabriela IlieUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 20 May 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.
Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. However, they typically incur both short- and long-term side effects (e.g. urinary incontinence, sexual dysfunction, reduced physical function, etc) that can negatively impact one's quality of life. This program of research aims to address the most critical needs of PC survivors: the development and evaluation of interventions to address the quality of life impact of PC. This study will test the Prostate Cancer Patient Empowerment Program (PC-PEP) in 400 men, a comprehensive intervention aimed at educating and teaching the men life skills/habits in order to improve their mental health issues, fitness levels and overall quality of life, and to decrease treatment related side effects. The program also aims to improve the overall health of the participants in the long term.
Detailed description
In a survey study of almost 400 survivors of prostate cancer (PC), the investigators found that 17% of them suffered currently from mental health issues, and most were not on medication to address this issue. Compounding issues included urinary and sexual disfunction, poor attendance to support groups, intimacy, problems sleeping and other health problems. To address these many issues directly, with the endorsement of physicians and patients attending our regional PC integrative care conference (April 2018) and expanding on pre-habitation (pre-surgery) science, the investigators created a Patient Empowerment Program (PEP) to be delivered from day one of diagnosis, to educate and teach the men and partners life skills/habits which are aimed to improve their fitness levels and quality of life, and to decrease treatment related side effects. This program is in line with the Auditor General of Nova Scotia's 2017 report endorsing the use of bottom-up evidence-based interventions, created from actively engaging patients in development and process. The investigators aim to trial PC-PEP for men undergoing curative treatment for PC versus a control group receiving standard care. The PC-PEP program includes in-person and multimedia informational, physical activity, pelvic floor, stress reduction, and relationship/connection training. The men are connected with other participants to increase social support and maximize compliance. Technology is used to deliver daily alerts to patients to remind them to engage in the program. A PC-PEP feasibility study of 30 men, over 28 days, showed that the program is feasible, leads to positive outcomes in patients and is highly (9.79/10) endorsed by patients. It is predicted that PC-PEP will improve mental health (primary outcome) and other quality of life outcomes of patients compared with 'usual care'.
A randomized, wait-list controlled clinical trial for men newly diagnosed with PC is currently underway. This next phase will open the program to more men and expand the inclusion criteria. Participants in the PC-PEP will receive the intervention for six months. Introducing a comprehensive empowerment program from day one of diagnosis may mitigate against the high levels of mental distress, short and long-term, suffered by hundreds of Nova Scotian men undergoing curative PC treatment every year, and the burden that treatment related side effects will place on our health care system. Given that the study has the endorsement of patients, clinicians and administrators at Nova Scotia Health, if proven successful it will have the evidence base needed to change the current standard of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Patient Empowerment Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >18
- History of a prostate cancer diagnosis
- Safe to exercise and do strength training (participants who have recovered from a minor stroke or heart condition in the past will require approval from their Family Physician or Cardiologist to participate in the study. Participants with advanced prostate cancer will need approval from the Study Physician or their Urologist or Oncologist to participate)
- Existing (or willingness to create) email account
- Willingness to access and use daily email and/or text messages
Key exclusion criteria (3 listed)
- Patients deemed unfit to participate in low level exercise eg. including but not limited to a myocardial infarction or stroke within the last year, without approval from their Family Physician or Cardiologist that they are safe to exercise.
- Unable to access the internet and lack of a computer or cellphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video.
- Men with a predicted survival less than 2 years.
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 |
|---|---|---|
| Patient Empowerment ProgramThe 6 months "at home" program focuses on aerobic and strength training, pelvic floor muscle exercises, meditation, social connection, and overall healthy lifestyle practices supported with daily text message/email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily and will be individualized to each participant. Pelvic floor muscle training will include three, 10-minute sessions and mediation for 10 minutes daily. Intimacy and Connection component of PC-PEP consists of engaging in at least one form of intimacy practice prescribed, per day. Social connection will be fostered by pairing participants up with peers from the study. To encourage program compliance, study participants will receive 3 daily reminders to do their pelvic floor muscle exercises per day plus an additional motivational email daily containing helpful tips. | Behavioural | Intervention Arm |
Primary outcome
Mental Health
Time frame: 6 - 24 months
Kessler 10 - assessment of psychological distress. Measured through on-line survey.
10 secondary outcomes
General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12)
Time frame: 6 - 24 months
Disease Specific Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: 6 - 24 months
Urinary, Bowel, Hormonal, and Sexual Function as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 6 - 24 months
Urinary Bother as assessed by the International Prostate Symptom Score (IPSS)
Time frame: 6 - 24 months
Health Care Utilization
Time frame: 6 - 24 months
Relationship Satisfaction as assessed by the Dyadic Adjustment Scale (DAS)
Time frame: 6 - 24 months
Diet as assessed by the Starting the Conversation (STC) Questionnaire
Time frame: 6 - 24 months
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 - 24 months
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease 6-item Scale)
Time frame: Baseline to 6 months; baseline to 12 months; baseline to 24 months.
Change in generalized anxiety symptoms (GAD-7)
Time frame: Baseline to 6 months; Baseline to 12 months, Baseline to 24 months.
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 18 Mar 2026.
- Derived from this study: PubMed 42782888Okedara O, Ilie G, Brodovsky M, Mason RJ, Rendon R, Kokorovic A, Bailly G, Evans H, Jana K, Nayak JG, Chan E, Flax S, Patil N, Bowes D, Ramiah D, Mutambirwa S, Oberholzer A, Riley L, Cole J, Carruthers W, Taylar S, Rutledge RDH. From Availability to Access: A Mixed-Methods Study of Digital Prostate Cancer Survivorship Support for Black Men. Curr Oncol. 2026 Sep 9;33(9):543. doi: 10.3390/curroncol33090543.
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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.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Empowerment Program in people with Prostate Cancer, run by Gabriela Ilie at 16 sites in 5 countries.
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 10 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada, South Africa, Belgium, New Zealand, Romania. 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?
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?
Contact Gabriela Ilie, PhD (902-989-4114, Gabriela.Ilie@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health (time frame: 6 - 24 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 NCT04895839, which also lists 1 linked publication.
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 18 Mar 2026.