Prostate CancerTURBONCT06518226
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer
A study testing Ultrahypofractionated MRgRT in 2 fractions in people with Prostate Cancer and Prostate Adenocarcinoma, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma
- What is being tested?
- Ultrahypofractionated MRgRT in 2 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2024to 1 Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Histopathological confirmation of prostate adenocarcinoma requiring radical treatment
- European Association of Urology (EAU) intermediate risk prostate cancer, defined as Prostate Specific Antigen (PSA) level of < 20 ng/ml, Gleason score ≤ 7, cT1c-cT2b/iT3a (non-bulky, < 20mm)
- Written informed consent
- Ability and willingness to comply with Patient Reported Outcome Measure (PROM) questionnaires schedule throughout the study
- Inclusion in the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM)
Who cannot join
- Contraindications to MRI
- International Prostate Symptom Score (IPSS) of 15 or higher
- Prostate volume > 80 cc
- Comorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease)
- Metal pelvic implants which cause artefact on MR-imaging sequences
- Previous radical prostatectomy
- Previous pelvic radiotherapy
- Previous invasive malignancy within the last 5 years, excluding basal cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584 CX
Tariq A Lalmahomed, MD, +31 (0)887574536, t.a.lalmahomed-2@umcutrecht.nl
Jochem R.N. Van der Voort van Zyp, MD PhD, j.r.n.vandervoortvanzyp@umcutrecht.nl
About this study
Official title: Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial
The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are:
- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects?
Participants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.
Read the detailed description
Rationale: Hypofractionation in prostate cancer radiotherapy has already led to a drastic reduction in fractionation scheme from 35 fractions to the now standard 5 fractions for patients with intermediate risk prostate cancer. Currently, biochemical progression free survival is at approximately 90% at five-year follow-up for intermediate risk prostate cancer patients, which leaves little to no room for further improvement in oncological outcomes. However, with an ageing population and a subsequently higher volume of patients with localized prostate cancer, there is a need to improve and optimize current treatment options. Treatment cost within the field of prostate oncology will further increase over the years to come, and an early economic health evaluation has demonstrated that a 2-fractionation scheme with MRI-guided radiotherapy (MRgRT) for intermediate risk prostate cancer patients is cost effective compared to the standard of care 5 fractions scheme.
Previous research demonstrated the feasibility of delivering high doses of radiation in only two fractions, both in silico as well as in a clinical setting using a conventional CT-guided linear accelerator. With the introduction of MRgRT, however, it has become possible to deliver higher doses of radiation with more accuracy, while limiting genitourinary (GU) and gastrointestinal (GI) toxicity. This leads us to believe that improvements can be made both in terms of costs as well as patient reported quality of life.
Objective: To assess the effectiveness, safety and feasibility of treating patients with localized, intermediate risk prostate cancer who will receive radiation therapy in two fractions of 12 Gy with a boost to the gross tumor volume of 13.5 Gy per fraction in 8 days, as compared to standard care (36.25 Gy in five fractions in 16-18 days), on an ELEKTA Unity MR-Linac system.
Study design: Single-center, prospective, open label, phase II randomized controlled trial.
Study population: Men with localized, intermediate risk prostate cancer who are to receive radiation therapy with curative intent. Exclusion criteria are previous radical prostatectomy, presence of contraindications for MRI or conditions which predispose to increased morbidity and/or toxicity (such as colitis ulcerosa, Crohn's disease), previous pelvic radiotherapy, metal pelvic implants causing artefact of MR-imaging, and previous invasive malignancy within the last 5 year (excluding cutaneous basal cell carcinoma)
Intervention: Participants in the intervention arm will receive two fractions of 12 Gy to the clinical target volume (CTV) with a boost up to 13.5 Gy to the gross tumor volume (GTV) of radiation in a time span of 8 days on an MR-linac. Those in the control arm will receive five fractions of 7.25 Gy in a time span of 16-18 days on an MR-linac, as per standard care.
Main study parameters/endpoints: Difference in proportion of participants with acute CTCAE grade 2 or higher GU toxicity.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This trial will be nested in the observational Multiple OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac (MOMENTUM) study, and participants will receive QOL questionnaires which are already embedded within this cohort. Therefore, participants are not subjected to an additional burden during the course and follow-up period of this study. In a recently published study, there was no evidence that hypofractionation caused more GU and/or GI grade ≥2 toxicity. Radiobiologically, the low alpha/beta ratio of prostate cancer makes it more sensitive to higher doses of radiation in fewer fractions, which is in fact the essence of the ultrahypofractionation scheme that we offer in the interventional arm.
- Being tested
- Ultrahypofractionated MRgRT in 2 fractions, Standard of care: MRgRT in 5 fractions
- Keywords
- MR-guided adaptive radiotherapy, MRgRT, Quality of life, Patient-reported outcomes, Ultrahypofractionation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrahypofractionated MRgRT in 2 fractionsRadiation
2x12 Gy with boost to GTV up to 13.5 Gy
Standard of care: MRgRT in 5 fractionsRadiation
5x7.25 Gy
| Study group | Role | What they receive |
|---|---|---|
| Ultrahypofractionated MRgRT in 2 fractions | Experimental | MRgRT to the prostate in 2 fractions of 12 Gy, with a focal boost of 13.5 Gy to the gross tumor volume (GTV), administered over the course of 8 days. Receives: Radiation: Ultrahypofractionated MRgRT in 2 fractions |
| Standard of care: MRgRT in 5 fractions | Active comparator | MRgRT to the prostate in 5 fractions of 7.25 Gy to the prostate without focal boost, administered over the course of 16-18 days. Receives: Radiation: Standard of care: MRgRT in 5 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity
This is scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale. Scores will be retrieved from the hospital information system.
Measured: 90 days after treatment
Secondary outcomes (7)
Incidence of acute grade >= 2 gastrointestinal (GI) physician-reported toxicity
This is scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale. Scores will be retrieved from the hospital information system.
Measured: Up to 5 years
Incidences of late grade >= 2 GU physician-reported toxicity
This is scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale. Scores will be retrieved from the hospital information system.
Measured: Up to 5 years
Incidences of acute grade >= 2 GI physician-reported toxicity
This is scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale. Scores will be retrieved from the hospital information system.
Measured: Up to 5 years
Oncological treatment related quality of life (QoL)
Oncological treatment related quality of life is captured through the generic European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire(QLQ)-C30. It includes 5 functional scales (physical, role, emotional, cognitive and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Measured: Up to 5 years
Patient reported Health related quality of life (HRQoL)
Generic patient reported quality of life is captured by the EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Measured: Up to 5 years
Patient reported prostate cancer-specific quality of life (QoL).
Prostate cancer-specific patient reported quality of life is captured by the tumor specific European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire(QLQ)-C30. The questionnaire consists of functional and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Measured: Up to 5 years
Biochemical progression free survival (bPFS)
Prostate Specific Antigen (PSA) levels in ng/mL will be retrieved from the hospital information system. Biochemical recurrence is defined as serum PSA levels that are 2 ng/mL higher than the nadir PSA achieved after treatment.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start28 Mar 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 UMC UtrechtThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.R.N. van der Voort van Zyp, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518226
- Sponsor's protocol ID
- NL85364.041.23
- Acronym
- TURBO
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Westley RL, Biscombe K, Dunlop A, Mitchell A, Oelfke U, Nill S, Murray J, Pathmanathan A, Hafeez S, Parker C, Ratnakumaran R, Alexander S, Herbert T, Hall E, Tree AC. Interim Toxicity Analysis From the Randomized HERMES Trial of 2- and 5-Fraction Magnetic Resonance Imaging-Guided Adaptive Prostate Radiation Therapy. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):682-687. doi: 10.1016/j.ijrobp.2023.09.032. Epub 2023 Sep 29.
PubMed 37776979Lalmahomed TA, Monninkhof EM, van Rijssel MJ, van Melick HHE, Verkooijen HM, de Boer JCJ, van der Voort van Zyp JRN. Two-fraction Ultrahypofractionated Radiotherapy with focal BOost for intermediate-risk, localized prostate cancer (TURBO): study protocol of a phase II, randomized controlled clinical trial. Trials. 2025 Dec 29;26(1):586. doi: 10.1186/s13063-025-09297-5.
PubMed 41466435
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06518226
- Acronym / sponsor ID
- TURBO / NL85364.041.23
- Keywords
- MR-guided adaptive radiotherapy, MRgRT, Quality of life, Patient-reported outcomes, Ultrahypofractionation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 24 Jul 2024 (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.
The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are:
- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects?
Participants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.
Detailed description
Rationale: Hypofractionation in prostate cancer radiotherapy has already led to a drastic reduction in fractionation scheme from 35 fractions to the now standard 5 fractions for patients with intermediate risk prostate cancer. Currently, biochemical progression free survival is at approximately 90% at five-year follow-up for intermediate risk prostate cancer patients, which leaves little to no room for further improvement in oncological outcomes. However, with an ageing population and a subsequently higher volume of patients with localized prostate cancer, there is a need to improve and optimize current treatment options. Treatment cost within the field of prostate oncology will further increase over the years to come, and an early economic health evaluation has demonstrated that a 2-fractionation scheme with MRI-guided radiotherapy (MRgRT) for intermediate risk prostate cancer patients is cost effective compared to the standard of care 5 fractions scheme.
Previous research demonstrated the feasibility of delivering high doses of radiation in only two fractions, both in silico as well as in a clinical setting using a conventional CT-guided linear accelerator. With the introduction of MRgRT, however, it has become possible to deliver higher doses of radiation with more accuracy, while limiting genitourinary (GU) and gastrointestinal (GI) toxicity. This leads us to believe that improvements can be made both in terms of costs as well as patient reported quality of life.
Objective: To assess the effectiveness, safety and feasibility of treating patients with localized, intermediate risk prostate cancer who will receive radiation therapy in two fractions of 12 Gy with a boost to the gross tumor volume of 13.5 Gy per fraction in 8 days, as compared to standard care (36.25 Gy in five fractions in 16-18 days), on an ELEKTA Unity MR-Linac system.
Study design: Single-center, prospective, open label, phase II randomized controlled trial.
Study population: Men with localized, intermediate risk prostate cancer who are to receive radiation therapy with curative intent. Exclusion criteria are previous radical prostatectomy, presence of contraindications for MRI or conditions which predispose to increased morbidity and/or toxicity (such as colitis ulcerosa, Crohn's disease), previous pelvic radiotherapy, metal pelvic implants causing artefact of MR-imaging, and previous invasive malignancy within the last 5 year (excluding cutaneous basal cell carcinoma)
Intervention: Participants in the intervention arm will receive two fractions of 12 Gy to the clinical target volume (CTV) with a boost up to 13.5 Gy to the gross tumor volume (GTV) of radiation in a time span of 8 days on an MR-linac. Those in the control arm will receive five fractions of 7.25 Gy in a time span of 16-18 days on an MR-linac, as per standard care.
Main study parameters/endpoints: Difference in proportion of participants with acute CTCAE grade 2 or higher GU toxicity.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This trial will be nested in the observational Multiple OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac (MOMENTUM) study, and participants will receive QOL questionnaires which are already embedded within this cohort. Therefore, participants are not subjected to an additional burden during the course and follow-up period of this study. In a recently published study, there was no evidence that hypofractionation caused more GU and/or GI grade ≥2 toxicity. Radiobiologically, the low alpha/beta ratio of prostate cancer makes it more sensitive to higher doses of radiation in fewer fractions, which is in fact the essence of the ultrahypofractionation scheme that we offer in the interventional arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Ultrahypofractionated MRgRT in 2 fractions | Experimental | Radiation: Ultrahypofractionated MRgRT in 2 fractionsMRgRT to the prostate in 2 fractions of 12 Gy, with a focal boost of 13.5 Gy to the gross tumor volume (GTV), administered over the course of 8 days. |
| Standard of care: MRgRT in 5 fractions | Active comparator | Radiation: Standard of care: MRgRT in 5 fractionsMRgRT to the prostate in 5 fractions of 7.25 Gy to the prostate without focal boost, administered over the course of 16-18 days. |
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)
- Age ≥18 years
- Histopathological confirmation of prostate adenocarcinoma requiring radical treatment
- European Association of Urology (EAU) intermediate risk prostate cancer, defined as Prostate Specific Antigen (PSA) level of < 20 ng/ml, Gleason score ≤ 7, cT1c-cT2b/iT3a (non-bulky, < 20mm)
- Written informed consent
- Ability and willingness to comply with Patient Reported Outcome Measure (PROM) questionnaires schedule throughout the study
Key exclusion criteria (8 listed)
- Contraindications to MRI
- International Prostate Symptom Score (IPSS) of 15 or higher
- Prostate volume > 80 cc
- Comorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease)
- Metal pelvic implants which cause artefact on MR-imaging sequences
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 |
|---|---|---|
| Ultrahypofractionated MRgRT in 2 fractions2x12 Gy with boost to GTV up to 13.5 Gy | Radiation | Ultrahypofractionated MRgRT in 2 fractions |
| Standard of care: MRgRT in 5 fractions5x7.25 Gy | Radiation | Standard of care: MRgRT in 5 fractions |
Primary outcome
Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity
Time frame: 90 days after treatment
This is scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale. Scores will be retrieved from the hospital information system.
7 secondary outcomes
Incidence of acute grade >= 2 gastrointestinal (GI) physician-reported toxicity
Time frame: Up to 5 years
Incidences of late grade >= 2 GU physician-reported toxicity
Time frame: Up to 5 years
Incidences of acute grade >= 2 GI physician-reported toxicity
Time frame: Up to 5 years
Oncological treatment related quality of life (QoL)
Time frame: Up to 5 years
Patient reported Health related quality of life (HRQoL)
Time frame: Up to 5 years
Patient reported prostate cancer-specific quality of life (QoL).
Time frame: Up to 5 years
Biochemical progression free survival (bPFS)
Time frame: Up to 5 years
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 24 Jul 2024.
- Background: PubMed 37776979Westley RL, Biscombe K, Dunlop A, Mitchell A, Oelfke U, Nill S, Murray J, Pathmanathan A, Hafeez S, Parker C, Ratnakumaran R, Alexander S, Herbert T, Hall E, Tree AC. Interim Toxicity Analysis From the Randomized HERMES Trial of 2- and 5-Fraction Magnetic Resonance Imaging-Guided Adaptive Prostate Radiation Therapy. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):682-687. doi: 10.1016/j.ijrobp.2023.09.032. Epub 2023 Sep 29.
- Derived from this study: PubMed 41466435Lalmahomed TA, Monninkhof EM, van Rijssel MJ, van Melick HHE, Verkooijen HM, de Boer JCJ, van der Voort van Zyp JRN. Two-fraction Ultrahypofractionated Radiotherapy with focal BOost for intermediate-risk, localized prostate cancer (TURBO): study protocol of a phase II, randomized controlled clinical trial. Trials. 2025 Dec 29;26(1):586. doi: 10.1186/s13063-025-09297-5.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrahypofractionated MRgRT in 2 fractions in people with Prostate Cancer and Prostate Adenocarcinoma, run by UMC Utrecht at 1 site in Netherlands.
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 8 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 24 Jul 2024. 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 Netherlands. 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 Tariq A. Lalmahomed, MD (+31 (0)887574536, t.a.lalmahomed-2@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity (time frame: 90 days after treatment). 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 NCT06518226, which also lists 2 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 24 Jul 2024.