Prostate CancerHYPROGENNCT05702619
Hypoxia-driven Prostate Cancer Genomics (HYPROGEN)
An observational study of Prostate Cancer and Hypoxia, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Due to the rapid growth, tumour demand for oxygen is often higher than what can be delivered by the newly forming blood vessels. Tumour adaption to this imbalanced oxygen supply and demand (hypoxia) is associated with poor prognosis and genetic changes (genomic instability) that allow it to become more resistant to… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Hypoxia
- What is being tested?
- Optional non-IMP pimonidazole, CT-guided Bone Biopsy and TRUS-guided Targeted Transperineal Prostate Biopsy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2021to 30 Jun 2023
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Arm 1 - De novo, treatment-naïve metastatic prostate cancer Arm 2 - De novo, treatment- naïve localised prostate cancer planned for radical prostatectomy
Who may be able to join
- Male patients aged 18 years and older
- Histologically proven adenocarcinoma of the prostate (≥cT2) or Highly suspected metastatic prostate cancer
- PSA value of ≥ 20 ng/mL
- Multiple lesions (≥ 5) suspicious of metastatic spread on routine imaging procedures with at least one amenable* to biopsy (cohort A) or oligometastatic bone disease (≥1 to ≤ 4) at routine bone scan with at least one lesion amenable* to biopsy (cohort B)
- e.g. safely to biopsy and expectably providing sufficient tissue yield World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 months
- No prior local and/or systemic treatment for localised prostate cancer
Show all 13Show fewer
- Willing to donate cancer tissue samples for research purposes (bone metastasis and primary tumour)
- Male patients aged 18 years and older cT¬2-T3 / cN0-N1 / cM0 Any Group Grade (GG) 2-5: this includes Gleason scores 3+4, 4+3, 4+4, 4+5, 5+3, 5+4, 5+5. Any PSA
- Histologically proven adenocarcinoma of the prostate
- Undergoing radical prostatectomy as primary treatment for localised prostate cancer
- World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 months
- No prior local and/or systemic treatment for localised prostate cancer
- Willing to donate cancer tissue samples for research purposes (any metastasis and primary tumour)
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to staff at the study site)
- Previous enrolment in the HYPROGEN study
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. uncompensated respiratory, cardiac, hepatic or renal disease)
- Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
- Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection
- Prior treatment of localized prostate cancer including radiotherapy and/or androgen-deprivation therapy
Show all 20Show fewer
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- Contra-indications to MRI (incl. pacemakers etc.)
- Bone metastases in difficult to reach areas or areas which might be at risk for pathological fracture post biopsy as judged by biopsying radiologist / chief investigator
- Increased risk of bleeding as a result of biopsy
- History of bleeding disorders or thrombocytopenia (platelets <100/nL)
- Concomitant treatment with anticoagulant therapy, e.g. warfarin/low molecular weight heparin or Anti-Xa-inhibitors and other NOACs, if temporary cessation medically not justifiable
- Current urinary tract infection (UTI) or prostatitis
- ARM 2
- Involvement in the planning and/or conduct of the study (applies to staff at the study site)
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. uncompensated respiratory, cardiac, hepatic or renal disease)
- Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection
- Prior treatment of localized prostate cancer including radiotherapy and/or androgen-deprivation therapy
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- Contra-indications to MRI (incl. pacemakers etc.)
Trial locations and contacts
1 site in 1 country.
Fizzah M Ali contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester
Martin Swinton, m.swinton@nhs.net
Fizzah M Ali, fizzah.ali@manchester.ac.uk
About this study
Official title: Hypoxia-driven Prostate Cancer Genomics (HYPROGEN) - Illuminating the Genomic Landscape of Hypoxia-driven Early Metastatic Prostate Cancer
Due to the rapid growth, tumour demand for oxygen is often higher than what can be delivered by the newly forming blood vessels. Tumour adaption to this imbalanced oxygen supply and demand (hypoxia) is associated with poor prognosis and genetic changes (genomic instability) that allow it to become more resistant to chemo- and radiotherapy. Patients with hypoxic tumours therefore die earlier. Limited information is available on hypoxia in newly diagnosed prostate cancer, especially to what degree hypoxia in the prostate tumour is associated with the presence of metastases to bones. The Hyprogen trial is a prospective, non-randomised, exploratory biopsy and imaging biomarker study recruiting 60 patients with prostate cancer to better establish the role of hypoxia in prostate cancer cells evolution and early metastatic spread.
Read the detailed description
Arm 1 of this study will aim to determine the association between hypoxia in the primary tumour with the presence of skeletal metastases and aim to determine if hypoxia is also present in the metastatic sites themselves. Arm 2 will aim to determine the genetic changes associated with hypoxia in cancers that have not spread outside the prostate. Hypoxia presence will be determined by using a hypoxia identifying stain (by giving a patient a tablet of the stain to take orally) and by identifying genomic alterations that are associated with hypoxia. After taking the tablet of the hypoxia marker (Pimonidazole) patients in Arm 1 will receive both a biopsy of the prostate and of one or two of the bone metastases. The presence or not as well as the degree of hypoxia in both sites will be assessed. Patients in Arm 2 will receive pimonidazole prior to a planned radical prostatectomy and the heterogeneity of hypoxia related genetic change throughout the prostate will assessed. Arm 2 patients will undergo MRI hypoxia imaging to validate the detection of pimonidazole marked hypoxic regions with a non-invasive imaging method.
- Conditions
- Prostate Cancer, Hypoxia
- Being tested
- Optional non-IMP pimonidazole, CT-guided Bone Biopsy, TRUS-guided Targeted Transperineal Prostate Biopsy, Radical Prostatectomy, Whole-body MRI
- Keywords
- genomic, multi-omic
- Medical subject headings
- Prostatic Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optional non-IMP pimonidazoleDrug
Also called Pimonidazole Hydrochloride
patients will be asked to ingest an oral formulation of pimonidazole hydrochloride (HCl) (Oral HypoxyprobeTM-1). Pimonidazole HCl is a marker for hypoxia in tumour tissue when ingested as an encapsulated solid. Following oral administration, pimonidazole distributes throughout the body where it covalently binds to normal and tumour tissues that have regions of low oxygen concentrations (pO2 of ≤ 10 mmHg at 37oC). The tissue binding can be visualised by immunohistochemistry / light microscopy. The capsules are to be taken within 8-16 hours (optimal timepoint 12 hours) before the planned first biopsy within Arm 1 and before radical prostatectomy for patients in Arm 2. If the patient refuses the pimonidazole, forgets to take it, or if it is not available, the patient can still participate in the study and their samples will be stained for hypoxia post-biopsy.
CT-guided Bone BiopsyDiagnostic test
A CT-guided biopsy of a bone metastasis that is deemed to be easy to biopsy and in an area without major risk for pathological fracture or bleeding will be taken during the biopsy visit. Patients will receive routine local anaesthetic of the region to be biopsied followed by thorough disinfection of the biopsy site with antiseptic wipes. Patients will be asked to fast on the day of the procedure and to have an intravenous cannula inserted to allow the use of medication causing minimal sedation (for example midazolam and/or fentanyl) during the procedure if required to alleviate discomfort or pain.
TRUS-guided Targeted Transperineal Prostate BiopsyDiagnostic test
Transperineal Prostate Biopsy will be performed following standard clinical practice of local department. This will include pre-operative oral analgesia and prophylactic antibiotic treatment according to local hospital policy for transperineal prostate biopsies.
Radical ProstatectomyProcedure or surgery
Radical Prostatectomy will be performed according to standard of care robotic approach and as relayed to the patient by the attending urologic surgeon. The side effects of the surgery are the ones reported in the literature and the latest participant information leaflet provided prior patient consent (e.g. risk of erection disfunction, incontinence, etc.).
Whole-body MRIDiagnostic test
Whole-body MR imaging (wbMRI) will be performed once, before or after the biopsy study visit, depending on available examination slots in the Department of Radiology. WbMRI images will allow comparison of the numbers of bone metastases detected by routine bone scan and wbMRI for sensitivity assessment of both techniques for oligometastatic disease.
Prostate MRI scansDiagnostic test
Patients within Arm 2 will be offered the option to undergo additional MR imaging of the pelvis in addition to any standard of care imaging acquired. In patients who agree to undergo additional scans, MRI scans will be performed on 2 occasions prior to the radical prostatectomy. MRI scans will be acquired on either the MR sim diagnostic scanner, on the MR Linac scanner or on both.
Baseline bloods - for germline testingOther
Arm 1 -
- 1-2 x 3.5mL blood samples collected into EDTA tubes for germ line DNA extraction and processing to PBMC for banking and future profiling of immune cell populations
- 1 x 10mL serum tubes for future, biobank related research projects, ie lipidomics, metabolics and microRNA analysis
ARM 2 -
A blood sample (maximum 20ml) will be taken for standard of care blood tests prior to prostatectomy including Full Blood Count, Renal Function and PSA. At the same time these standard of care bloods are taken, additional bloods - a maximum of 30ml - will be taken for research purposes as required for the following downstream analysis:
- Germ line DNA extraction and optional processing to PBMC for banking and future profiling of immune cell populations
- Biobank related research projects, ie lipidomics, metabolics and microRNA analysis
Baseline bloods for CTCs and ct DNA taken at same time as baseline bloods in Arm 1Other
2 x 10mL Streck cell-free DNA blood collection tubes® for circulating tumour cell (CTC) collection and circulating tumour DNA (ctDNA) extraction.
Post-pimonidazole bloods for CTCs and ctDNAOther
ARM 1 - 2 x 10mL Streck cell-free DNA blood collection tubes® for circulating tumour cell (CTC) collection and circulating tumour DNA (ctDNA) extraction.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Arm 1 - De novo, treatment-naïve metastatic prostate cancer Receives: Drug: Optional non-IMP pimonidazole; Diagnostic Test: CT-guided Bone Biopsy; Diagnostic Test: TRUS-guided Targeted Transperineal Prostate Biopsy; Diagnostic Test: Whole-body MRI; Other: Baseline bloods - for germline testing; Other: Baseline bloods for CTCs and ct DNA taken at same time as baseline bloods in Arm 1; Other: Post-pimonidazole bloods for CTCs and ctDNA | |
| Arm 2 | Arm 2 - De novo, treatment- naïve localised prostate cancer planned for radical prostatectomy Receives: Drug: Optional non-IMP pimonidazole; Procedure: Radical Prostatectomy; Diagnostic Test: Prostate MRI scans; Other: Baseline bloods - for germline testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
To document the differential genomic aberrations and gene expressional alterations in hormone-naïve primary prostate cancers and paired skeletal metastases with respect to the presence or abscence of tissue hypoxia in the tumour samples.
Measured: 24 months
Secondary outcomes (1)
Secondary outcome measure
To determine extent of CTCs DNA in treatment naive metastatic prostate cancer in the presence or absence of hypoxia
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start3 Oct 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702619
- Sponsor's protocol ID
- CFTSp155
- Acronym
- HYPROGEN
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia-driven Prostate Cancer Genomics (HYPROGEN) - Illuminating the Genomic Landscape of Hypoxia-driven Early Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT05702619
- Acronym / sponsor ID
- HYPROGEN / CFTSp155
- Conditions
- Prostate Cancer, Hypoxia
- Keywords
- genomic, multi-omic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Prostate Cancer UK
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Jan 2023 (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.
Due to the rapid growth, tumour demand for oxygen is often higher than what can be delivered by the newly forming blood vessels. Tumour adaption to this imbalanced oxygen supply and demand (hypoxia) is associated with poor prognosis and genetic changes (genomic instability) that allow it to become more resistant to chemo- and radiotherapy. Patients with hypoxic tumours therefore die earlier. Limited information is available on hypoxia in newly diagnosed prostate cancer, especially to what degree hypoxia in the prostate tumour is associated with the presence of metastases to bones. The Hyprogen trial is a prospective, non-randomised, exploratory biopsy and imaging biomarker study recruiting 60 patients with prostate cancer to better establish the role of hypoxia in prostate cancer cells evolution and early metastatic spread.
Detailed description
Arm 1 of this study will aim to determine the association between hypoxia in the primary tumour with the presence of skeletal metastases and aim to determine if hypoxia is also present in the metastatic sites themselves. Arm 2 will aim to determine the genetic changes associated with hypoxia in cancers that have not spread outside the prostate. Hypoxia presence will be determined by using a hypoxia identifying stain (by giving a patient a tablet of the stain to take orally) and by identifying genomic alterations that are associated with hypoxia. After taking the tablet of the hypoxia marker (Pimonidazole) patients in Arm 1 will receive both a biopsy of the prostate and of one or two of the bone metastases. The presence or not as well as the degree of hypoxia in both sites will be assessed. Patients in Arm 2 will receive pimonidazole prior to a planned radical prostatectomy and the heterogeneity of hypoxia related genetic change throughout the prostate will assessed. Arm 2 patients will undergo MRI hypoxia imaging to validate the detection of pimonidazole marked hypoxic regions with a non-invasive imaging method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: Optional non-IMP pimonidazole, Diagnostic Test: CT-guided Bone Biopsy, Diagnostic Test: TRUS-guided Targeted Transperineal Prostate Biopsy, Diagnostic Test: Whole-body MRI, Other: Baseline bloods - for germline testing, Other: Baseline bloods for CTCs and ct DNA taken at same time as baseline bloods in Arm 1, Other: Post-pimonidazole bloods for CTCs and ctDNAArm 1 - De novo, treatment-naïve metastatic prostate cancer |
| Arm 2 | – | Drug: Optional non-IMP pimonidazole, Procedure: Radical Prostatectomy, Diagnostic Test: Prostate MRI scans, Other: Baseline bloods - for germline testingArm 2 - De novo, treatment- naïve localised prostate cancer planned for radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Arm 1 - De novo, treatment-naïve metastatic prostate cancer Arm 2 - De novo, treatment- naïve localised prostate cancer planned for radical prostatectomy
Key inclusion criteria (13 listed)
- Male patients aged 18 years and older
- Histologically proven adenocarcinoma of the prostate (≥cT2) or Highly suspected metastatic prostate cancer
- PSA value of ≥ 20 ng/mL
- Multiple lesions (≥ 5) suspicious of metastatic spread on routine imaging procedures with at least one amenable* to biopsy (cohort A) or oligometastatic bone disease (≥1 to ≤ 4) at routine bone scan with at least one lesion amenable* to biopsy (cohort B)
- e.g. safely to biopsy and expectably providing sufficient tissue yield World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 months
Key exclusion criteria (20 listed)
- Involvement in the planning and/or conduct of the study (applies to staff at the study site)
- Previous enrolment in the HYPROGEN study
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. uncompensated respiratory, cardiac, hepatic or renal disease)
- Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
- Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection
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 |
|---|---|---|
| Optional non-IMP pimonidazoleAlso: Pimonidazole Hydrochloridepatients will be asked to ingest an oral formulation of pimonidazole hydrochloride (HCl) (Oral HypoxyprobeTM-1). Pimonidazole HCl is a marker for hypoxia in tumour tissue when ingested as an encapsulated solid. Following oral administration, pimonidazole distributes throughout the body where it covalently binds to normal and tumour tissues that have regions of low oxygen concentrations (pO2 of ≤ 10 mmHg at 37oC). The tissue binding can be visualised by immunohistochemistry / light microscopy. The capsules are to be taken within 8-16 hours (optimal timepoint 12 hours) before the planned first biopsy within Arm 1 and before radical prostatectomy for patients in Arm 2. If the patient refuses the pimonidazole, forgets to take it, or if it is not available, the patient can still participate in the study and their samples will be stained for hypoxia post-biopsy. | Drug | Arm 1, Arm 2 |
| CT-guided Bone BiopsyA CT-guided biopsy of a bone metastasis that is deemed to be easy to biopsy and in an area without major risk for pathological fracture or bleeding will be taken during the biopsy visit. Patients will receive routine local anaesthetic of the region to be biopsied followed by thorough disinfection of the biopsy site with antiseptic wipes. Patients will be asked to fast on the day of the procedure and to have an intravenous cannula inserted to allow the use of medication causing minimal sedation (for example midazolam and/or fentanyl) during the procedure if required to alleviate discomfort or pain. | Diagnostic test | Arm 1 |
| TRUS-guided Targeted Transperineal Prostate BiopsyTransperineal Prostate Biopsy will be performed following standard clinical practice of local department. This will include pre-operative oral analgesia and prophylactic antibiotic treatment according to local hospital policy for transperineal prostate biopsies. | Diagnostic test | Arm 1 |
| Radical ProstatectomyRadical Prostatectomy will be performed according to standard of care robotic approach and as relayed to the patient by the attending urologic surgeon. The side effects of the surgery are the ones reported in the literature and the latest participant information leaflet provided prior patient consent (e.g. risk of erection disfunction, incontinence, etc.). | Procedure or surgery | Arm 2 |
| Whole-body MRIWhole-body MR imaging (wbMRI) will be performed once, before or after the biopsy study visit, depending on available examination slots in the Department of Radiology. WbMRI images will allow comparison of the numbers of bone metastases detected by routine bone scan and wbMRI for sensitivity assessment of both techniques for oligometastatic disease. | Diagnostic test | Arm 1 |
| Prostate MRI scansPatients within Arm 2 will be offered the option to undergo additional MR imaging of the pelvis in addition to any standard of care imaging acquired. In patients who agree to undergo additional scans, MRI scans will be performed on 2 occasions prior to the radical prostatectomy. MRI scans will be acquired on either the MR sim diagnostic scanner, on the MR Linac scanner or on both. | Diagnostic test | Arm 2 |
| Baseline bloods - for germline testingArm 1 - * 1-2 x 3.5mL blood samples collected into EDTA tubes for germ line DNA extraction and processing to PBMC for banking and future profiling of immune cell populations * 1 x 10mL serum tubes for future, biobank related research projects, ie lipidomics, metabolics and microRNA analysis ARM 2 - A blood sample (maximum 20ml) will be taken for standard of care blood tests prior to prostatectomy including Full Blood Count, Renal Function and PSA. At the same time these standard of care bloods are taken, additional bloods - a maximum of 30ml - will be taken for research purposes as required for the following downstream analysis: * Germ line DNA extraction and optional processing to PBMC for banking and future profiling of immune cell populations * Biobank related research projects, ie lipidomics, metabolics and microRNA analysis | Other | Arm 1, Arm 2 |
| Baseline bloods for CTCs and ct DNA taken at same time as baseline bloods in Arm 12 x 10mL Streck cell-free DNA blood collection tubes® for circulating tumour cell (CTC) collection and circulating tumour DNA (ctDNA) extraction. | Other | Arm 1 |
| Post-pimonidazole bloods for CTCs and ctDNAARM 1 - 2 x 10mL Streck cell-free DNA blood collection tubes® for circulating tumour cell (CTC) collection and circulating tumour DNA (ctDNA) extraction. | Other | Arm 1 |
Primary outcome
Primary outcome measure
Time frame: 24 months
To document the differential genomic aberrations and gene expressional alterations in hormone-naïve primary prostate cancers and paired skeletal metastases with respect to the presence or abscence of tissue hypoxia in the tumour samples.
1 secondary outcome
Secondary outcome measure
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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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.
Fizzah M Ali contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Hypoxia, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
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 13 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Swinton (07896026629, m.swinton@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2023.