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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Kasia Smigielska


Mr Martin J. Connor


Prof Hashim U. Ahmed
+44 (0)2033115473
atlanta@imperial.ac.uk


Mr Taimur Shah


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Local cytoreductive treatments for men with newly diagnosed metastatic prostate cancer in addition to standard of care treatment
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Local cytoreductive treatments for men with newly diagnosed metastatic prostate cancer in addition to standard of care treatment

Not Recruiting

Open to: Male

Age: Adult

London Wirral Southampton London Dartford Oxford London London Sunderland King's Lynn Harrow Newcastle upon Tyne Birkenhead Exeter London Wrexham London Isleworth High Wycombe London

Medical Conditions

Prostate cancer
metastatic disease (Any T, Any N, M1+) of any grade, stage or Prostate Specific Antigen (PSA) level

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

10 Apr 2019 31 Aug 2024

Interventional

Intervention Type : Mixed
Intervention Description : Current interventions as of 23/08/2023:Stratified randomisation via the electronic platform REDCap database.

Intervention Arm 1:Minimally Invasive Ablative Therapy (MIAT) to prostate in addition to SOC systemic treatment. The exact treatment protocol and modality used (cryotherapy or high intensity focused ultrasound, HIFU) will be set within the MIAT SOP. For those patients who are undergoing MIAT no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons. MIAT can be provided by a site other than the recruiting site with follow-up visits at recruiting site.

Intervention Arm 2:Radical therapy (prostatectomy or external beam radiotherapy [Prostate radiotherapy using a dose of external beam radiotherapy of 60Gy/20Fr over 27 days OR 74-78Gy in 2Gy per fraction with or without simultaneous nodal radiotherapy, as defined in Local Radiotherapy SOP]) in addition to SOC systemic treatment. Modality based on physician and patient preference and patient co-morbidities. Radiotherapy or surgery can be provided by a site other than the recruiting site with follow-up visits at the recruiting site. The surgical technique is at the discretion and expertise of the surgical team but will be laid down in the Prostatectomy SOP. For those patients who are undergoing radical prostatectomy no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons. The radiotherapy doses and protocol in this arm will be higher defined in the Radiotherapy Intervention Arm 2 SOP.

Metastases Directed Therapy (Intervention Arm 1 and 2):In both intervention arms 1 and 2, metastases directed therapy (MDT) may be used but intent to use MDT to be declared prior to randomisation. In the case of a metastatic recurrence after MDT, a re-treatment with MDT would be allowed if there were new metastatic areas/locations.

The imaging reporting of metastases as well as doses and protocol for MDT as defined in and determined by an Imaging Reporting SOP and a Metastases-Directed Therapy SOP.

Treatment duration of trial therapies: Prostatectomy 1 day; Radiotherapy 4 to 7.5 weeks; Minimally invasive therapy (MIAT) 1 day

[68Ga]PSMA-11 PET-CT Sub study--Now completed:The trialists will also ask men in the pilot part of ATLANTA if they are willing to undergo a PSMA PET scan. They want to see if this scan might be as accurate in detecting residual disease as prostate biopsies and standard body scans, like MRI, CT or bone scans. This however is optionaland participants will be told that they do not have to agree to take part in this optional research, but can still take part in the ATLANTA study. The tests required for this exploratory research will be explained to patients prior to consent in the Patient Information Sheet and verbally byclinician. The target recruitment for this study is 25 patients.

Previous interventions from 08/07/2021 to 23/08/2023:Stratified randomisation via the electronic platform known as the InForm database.

Intervention Arm 1:Minimally Invasive Ablative Therapy (MIAT) to prostate in addition to standard of care systemic treatment. The exact treatment protocol and modality used (cryotherapy or high intensity focused ultrasound, HIFU) will be set within the MIAT SOP. For those patients who are undergoing MIAT no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons.

Intervention Arm 2:Radical therapy with either prostatectomy or external beam radiotherapy (high radical dose set out in Radiotherapy Intervention Arm 2 SOP) in addition to standard of care systemic treatment. Modality based on physician and patient preference and patient co-morbidities. The surgical technique is at the discretion and expertise of the surgical team but will be laid down in the Prostatectomy SOP. For those patients who are undergoing radical prostatectomy no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons.

Metastases Directed Therapy (Intervention Arm 1 and 2):In both intervention arms 1 and 2, metastases directed therapy (MDT) may be used but intent to use MDT to be declared prior to randomisation. In the case of a metastatic recurrence after MDT, a re-treatment with MDT would be allowed if there were new metastatic areas/locations. The imaging reporting of metastases as well as doses and protocol for MDT will be defined and determined by an Imaging Reporting SOP and a Metastases-Directed Therapy SOP.

In total, 80 men will be approached in 10 UK centre to estimate recruitment rate, acceptability of the trial randomisation, reported toxicities and adherence to trial interventions in a pilot phase- this phase has now been successfully completed. They will also be included into the main phase where 918 will be recruited over 30 UK centres- current phase. Participants will remain in the study for a maximum of 4 years. The aims are to see whether men will participate in this trial (pilot) before a larger trial (main) is run, and the impact of these treatments on quality of life.

[68Ga]PSMA-11 PET-CT substudy:The trialists will also ask men in the pilot part of ATLANTA if they are willing to undergo a PSMA PET scan. They want to see if this scan might be as accurate in detecting residual disease as prostate biopsies and standard body scans, like MRI, CT or bone-scans. This however is optional and participants will be told that they do not have to agree to take part in this optional research, but can still take part in the ATLANTA study. The tests required for this exploratory research will be explained to patients prior to consent in the Patient Information Sheet and verbally by clinician. Target recruitment for this study is 25 patients. This substudy has now successfully been completed and we are not recruiting into this as we are now in the main phase of the trial.

Previous interventions:Stratified randomisation via the electronic platform known as the InForm database.

Intervention Arm 1:Minimally Invasive Ablative Therapy (MIAT) to prostate in addition to standard of care systemic treatment. The exact treatment protocol and modality used (cryotherapy or high intensity focused ultrasound, HIFU) will be set within the MIAT SOP. For those patients who are undergoing MIAT no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons.

Intervention Arm 2:Radical therapy with either prostatectomy or external beam radiotherapy (high radical dose set out in Radiotherapy Intervention Arm 2 SOP) in addition to standard of care systemic treatment. Modality based on physician and patient preference and patient co-morbidities. The surgical technique is at the discretion and expertise of the surgical team but will be laid down in the Prostatectomy SOP. For those patients who are undergoing radical prostatectomy no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons.

Metastases Directed Therapy (Intervention Arm 1 and 2):In both intervention arms 1 and 2, metastases directed therapy (MDT) may be used but intent to use MDT to be declared prior to randomisation. In the case of a metastatic recurrence after MDT, a re-treatment with MDT would be allowed if there were new metastatic areas/locations. The imaging reporting of metastases as well as doses and protocol for MDT will be defined and determined by an Imaging Reporting SOP and a Metastases-Directed Therapy SOP.

In total, 80 men will be approached in 10 UK centre to estimate recruitment rate, acceptability of the trial randomisation, reported toxicities and adherence to trial interventions in a pilot phase. They will also be included into the main phase where 918 will be recruited over 30 UK centres. Participants will remain in the study for a maximum of 4 years. The aims are to see whether men will participate in this trial (pilot) before a larger trial (main) is run, and the impact of these treatments on quality of life.

[68Ga]PSMA-11 PET-CT substudy:The trialists will also ask men in the pilot part of ATLANTA if they are willing to undergo a PSMA PET scan. They want to see if this scan might be as accurate in detecting residual disease as prostate biopsies and standard body scans, like MRI, CT or bone-scans. This however is optional and participants will be told that they do not have to agree to take part in this optional research, but can still take part in the ATLANTA study. The tests required for this exploratory research will be explained to patients prior to consent in the Patient Information Sheet and verbally by clinician. Target recruitment for this study is 25 patients.




You can take part if:



You may not be able to take part if:


Added 23/08/2023: Current exclusion criteria as of 06/10/2021:1. Patient did not undergo and/or is unable to undergo standard of care baseline imaging tests for confirmation of metastatic status (CT abdomen/pelvis AND chest X-ray (or CT chest) AND radioisotope bone scan (or whole body imaging such as MRI or PET imaging as alternative to all preceding scans mentioned here) AND prostate MRI.2. Prior exposure to long-term androgen deprivation therapy or hormonal therapy for the treatment of prostate cancer unless started within 6 months of screening visit.3. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above)

Previous exclusion criteria from 08/02/2021 to 06/10/2021: 1. Patient did not undergo and/or is unable to undergo standard of care baseline imaging tests for confirmation of metastatic status (CT abdomen/pelvis AND chest X-Ray (or CT chest) AND radioisotope bone scan (or whole body imaging such as MRI or PET imaging as alternative to allpreceding scans mentioned here) AND prostate MRI2. Prior exposure to long-term androgen deprivation therapy or hormonal therapy for the treatment of prostate cancer unless started within 4 months of screening visit3. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above in Exclusion Criteria 2)

Previous exclusion criteria:1. Patient did not undergo and/or is unable to undergo standard of care baseline imaging tests for confirmation of metastatic status (CT abdomen/pelvis AND chest X-Ray (or CT chest) AND radioisotope bone scan (or whole body imaging such as MRI or PET imaging as alternative to all preceding scans mentioned here) AND prostate MRI2. Prior exposure to long-term androgen deprivation therapy or hormonal therapy for the treatment of prostate cancer unless started within 3 months of randomisation3. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above in Exclusion Criteria 2)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University College London Hospitals NHS Foundation Trust
    250 Euston Road
    London
    NW1 2PG
  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Clatterbridge Hospital Clatterbridge Road Bebington
    Wirral
    CH63 4JY
  • Southampton General Hospital
    Tremona Road
    Southampton
    SO16 6YD
  • Kings College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Darent Valley Hospital
    Darenth Wood Road
    Dartford
    DA2 8DA
  • Oxford University Hospitals NHS Foundation Trust
    Churchill Hospital Old Road Headington
    Oxford
    OX3 7LE
  • Royal Marsden Hospital
    203 Fulham Road Chelsea
    London
    SW3 6JJ
  • Charing Cross Hospital, Imperial College Healthcare NHS Trust
    Fulham Palace Road, Hammersmith
    London
    W6 8RF
  • Sunderland Royal Hospital 
    Kayll Road
    Sunderland
    SR4 7TP
  • Cambridge Queen Elizabeth Hospital, Kings Lynn
    Gayton Road, King's Lynn
    King's Lynn
    PE30 4ET
  • Northwick Park, London North West Healthcare NHS Trust
    Watford Rd
    Harrow
    HA1 3UJ
  • Freeman Hospital
    Newcastle upon Tyne Hospitals NHS Foundation Trust Freeman Rd High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Wirral University Teaching Hospital
    Wirral University Teaching Hospital NHS Foundation Trust Arrowe Park Rd
    Birkenhead
    CH49 5PE
  • Royal Devon and Exeter NHS Trust
    Barrack Road
    Exeter
    EX2 5DW
  • Croydon University Hospital
    530 London Road Thornton Heath
    London
    CR7 7YE
  • Glan Clwyd Hospital
    North Wales Clinical Research Centre NWCRC Unit 5 Gwenfro
    Wrexham
    LL13 7YP
  • Chelsea and Westminister
    369 Fulham Road
    London
    SW10 9NH
  • West Middlesex University Hospital
    Twickenham Road
    Isleworth
    TW7 6A
  • Wycombe Hospital
    Queen Alexandra Road
    High Wycombe
    HP11 2TT
  • North Middlesex University Hospital Trust
    North Middlesex Hospital Sterling Way
    London
    N18 1QX

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Mr Taimur Shah


Prof Hashim U. Ahmed
+44 (0)2033115473
atlanta@imperial.ac.uk


Ms Kasia Smigielska


Mr Martin J. Connor



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Imperial College London and Imperial College Healthcare NHS Trust and funded by Wellcome Trust.




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Read full details for Trial ID: ISRCTN58401737

Or CPMS 40854

Last updated 23 August 2023

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