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Additional Treatments to the Local Tumour for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms (IP2-ATLANTA)

Primary Purpose

Prostate Cancer, Metastatic Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Standard of Care
Minimally Invasive Ablative Therapy (MIAT)
Radical Therapy (Prostatectomy or Radiotherapy)
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with prostate cancer within 6 months of screening visit
  2. Metastatic disease (Any T, Any N, M1+) of any grade, stage or Prostate Specific Antigen (PSA) level.
  3. Fit to undergo standard of care treatment for metastatic disease and both minimally invasive therapy and prostate radiotherapy/prostatectomy.
  4. Performance status 0-2
  5. Histologically proven local tumour

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 Xray (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 4 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)

Sites / Locations

  • Wirral University Teaching Hospital, Wirral University Teaching Hospital NHS Foundation TrustRecruiting
  • Glan Clwyd HospitalRecruiting
  • Darent Valley HospitalRecruiting
  • Royal Devon and Exeter NHS TrustRecruiting
  • Buckinghamshire Healthcare NHS TrustRecruiting
  • West Middlesex University HospitalRecruiting
  • Queen Elizabeth Hospital, Kings LynnRecruiting
  • Chelsea and Westminster HospitalRecruiting
  • The Royal Marsden NHS Foundation Trust, Chelsea Research CentreRecruiting
  • Imperial College Healthcare NHS TrustRecruiting
  • North Middlesex University HospitalRecruiting
  • Northwick Park, London North West Healthcare NHS TrustRecruiting
  • St George's University HospitalRecruiting
  • University College London HospitalRecruiting
  • Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation TrustRecruiting
  • Oxford University HospitalRecruiting
  • Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)Recruiting
  • Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation TrustRecruiting
  • Croydon University HospitalRecruiting
  • Southend University HospitalRecruiting
  • Clatterbridge Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control Arm: Standard of Care (SOC)

Intervention Arm 1: Minimally Invasive Ablative Therapy (MIAT)

Intervention Arm 2: Radical Therapy

Arm Description

Standard of Care (SOC) treatment as determined by treating physician (positive control) (androgen deprivation with or without docetaxel chemotherapy or other systemic standard of care treatment including but not limited to Abiraterone or Enzalutamide). Radiotherapy to the prostate in this arm is defined as cytoreductive (for symptom control) in high volume (>/=4) metastases or to mirror current accepted local radiotherapy dose regimens for men with low volume metastases (<4 metastases). Metastases directed therapy will not be permitted in the control arm. Palliative radiotherapy for symptom control or for prevention of fracture will be permitted as standard clinical practice.

MIAT to prostate in form of cryotherapy or high intensity focused ultrasound (HIFU), in addition to SOC systemic treatment. No local prostate radiotherapy will be given as part of this intervention. Radiotherapy can be given subsequently for palliative reasons. Metastatic directed therapy will be available for use in this arm (if declared at randomisation).

Radical therapy in form of prostatectomy (any approach) or external beam radiotherapy (radical dose) in addition to SOC systemic treatment. Modality based on physician and patient preference and patient co-morbidities. For patients undergoing radical prostatectomy no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons. Radical radiotherapy doses in this arm will be higher than SOC. Metastatic directed therapy will be available for use in this arm (if declared at randomisation).

Outcomes

Primary Outcome Measures

Prostate cancer on post-standard of care prostate biopsy.
Proportion of patients with complete pathological response, measured on post SOC (systemic therapy) prostate biopsies (Internal Pilot).
Safety (Adverse Events)
Safety (Adverse Events), measured using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Grade 1-5.
Progression-free survival (PFS)
Progression-free survival (PFS), measured as a composite outcome of Biochemical failure (PSA progression value) or Local progression or Lymph node progression or Bone metastases progression (new sites) or Progression or development of new distant metastases, defined as lymph nodes outside the pelvis, bone or organ involvement or Skeletal-related events confirmed as progression as in the Systemic Therapy in Advancing Or Metastatic Prostate Cancer: Evaluation Of Drug Efficacy (STAMPEDE) RCT).

Secondary Outcome Measures

Urinary side effects
Urinary side effects, measured using the IPSS questionnaire, Score 0-35.
Sexual side effects
Sexual side effects, measured using the IIEF15 questionnaire, Score 0-75.
Rectal side effects
Rectal side effects, measured using the EPIC bowel and bladder questionnaire, Score 14-113.
Progression (Biochemical / Radiological / Clinical)
Progression on PSA and imaging and impact of clinical features on progression, measured using PSA blood tests
Health-related quality-of-life
Health-related quality-of-life, measured using EuroQol (EQ-5D-5L) questionnaire, Score 0-100.

Full Information

First Posted
November 12, 2018
Last Updated
August 16, 2023
Sponsor
Imperial College London
Collaborators
Wellcome Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03763253
Brief Title
Additional Treatments to the Local Tumour for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms
Acronym
IP2-ATLANTA
Official Title
Local Cytoreductive Treatments for Men With Newly Diagnosed Metastatic Prostate Cancer in Addition to Standard of Care Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Wellcome Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Local cytoreductive treatments for men with newly diagnosed metastatic prostate cancer in addition to standard of care treatment
Detailed Description
TITLE: Additional Treatments to the Local tumour for metastatic prostate cancer: Assessment of Novel Treatment Algorithms (ATLANTA) OBJECTIVES: To determine whether the addition of local treatment to the prostate (minimally invasive therapy or radical therapy [prostatectomy or radiotherapy]), including selective metastases-directed therapy, improves oncological outcomes in men receiving standard of care treatment for newly diagnosed metastatic prostate cancer PHASE: Phase II Randomised Control Trial (RCT) incorporating an internal pilot DESIGN: Three-arm unblinded randomised controlled trial using a positive control SAMPLE SIZE: 399 POPULATION: Men who are willing to undergo local therapy to the prostate and selective metastases-directed therapy for metastatic prostate cancer in addition to standard care systemic treatment. STUDY HYPOTHESIS: We hypothesise that men with metastatic disease who undergo treatment of the local tumour in the form of either radical therapy (prostatectomy or radiotherapy) or minimally invasive ablative therapy (MIAT), combined with metastases directly therapy, will have improved survival compared to those who receive standard of treatment alone. We will be investigating this newly evolving treatment paradigm in a formal randomised control trial (RCT). TREATMENT/MAIN STUDY PROCEDURES: (including treatment duration and follow-up) Our pragmatic design ensures all eligible patients can be approached and randomised as there is no requirement for fitness to undergo RP. The design also incorporates the latest approach for standard of care as well as management of lymph nodes. Arm 1*: Standard of Care (SOC) treatment as determined by treating physician (positive control) (androgen deprivation with or without Docetaxel chemotherapy or other systemic/local directed standard of care treatment including but not limited to Abiraterone or Enzalutamide). Radiotherapy in this arm defined as palliative/cytoreductive in high volume metastases or to mirror STAMPEDE local radiotherapy arm in low volume metastases. Arm 2**: Minimally Invasive Ablative Therapy (MIAT) to local tumour / prostate in addition to SOC systemic treatment. Predominantly cryotherapy but based on disease characteristics, HIFU also. Metastases directed therapy declared prior to randomisation. Arm 3**: Radical therapy (Prostatectomy or External beam radiotherapy [60Gy x 20 or 74Gy + in 32-37 weeks]) in addition to SOC systemic treatment. Modality based on physician and patient preference and patient co-morbidities. Metastases directed therapy declared prior to randomisation. FOLLOW-UP DURATION: Until progression or minimum 2-years or maximum 4 years whichever is first (or 6 months for the Pilot if the trial does not progress to Phase II). Prior to enrolment all patients must undergo Standard of Care (SOC) staging investigations for localised and metastatic disease and will need to have histologically proven local disease within the prostate. There will be no restriction on the type of biopsy used for diagnosis. *ADT but not chemotherapy may be initiated prior to recruitment.The decision as to which SOC systemic therapy regimen will be used is by the treating clinician and/or clinical team (to be declared upfront prior to randomisation). If radiotherapy is planned for local disease in some cases in the SOC arm then this will be declared upfront prior to randomisation by the treating physician. Similarly, if lymph node radiotherapy is to be advocated then this is to be declared upfront prior to randomisation by the treating physician and can be applied to any one of the three arms. Randomisation into a treatment arm would occur at the time of recruitment which would be within 3 months of starting SOC systemic therapy. Extra blood and urine samples will be identified using a special study number assigned to each patient, in such a way that the scientists analysing them will not be able to find out patients identity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Metastatic Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
Three-arm unblinded randomised controlled trial using a positive control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
399 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm: Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
Standard of Care (SOC) treatment as determined by treating physician (positive control) (androgen deprivation with or without docetaxel chemotherapy or other systemic standard of care treatment including but not limited to Abiraterone or Enzalutamide). Radiotherapy to the prostate in this arm is defined as cytoreductive (for symptom control) in high volume (>/=4) metastases or to mirror current accepted local radiotherapy dose regimens for men with low volume metastases (<4 metastases). Metastases directed therapy will not be permitted in the control arm. Palliative radiotherapy for symptom control or for prevention of fracture will be permitted as standard clinical practice.
Arm Title
Intervention Arm 1: Minimally Invasive Ablative Therapy (MIAT)
Arm Type
Active Comparator
Arm Description
MIAT to prostate in form of cryotherapy or high intensity focused ultrasound (HIFU), in addition to SOC systemic treatment. No local prostate radiotherapy will be given as part of this intervention. Radiotherapy can be given subsequently for palliative reasons. Metastatic directed therapy will be available for use in this arm (if declared at randomisation).
Arm Title
Intervention Arm 2: Radical Therapy
Arm Type
Active Comparator
Arm Description
Radical therapy in form of prostatectomy (any approach) or external beam radiotherapy (radical dose) in addition to SOC systemic treatment. Modality based on physician and patient preference and patient co-morbidities. For patients undergoing radical prostatectomy no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons. Radical radiotherapy doses in this arm will be higher than SOC. Metastatic directed therapy will be available for use in this arm (if declared at randomisation).
Intervention Type
Combination Product
Intervention Name(s)
Standard of Care
Intervention Description
Androgen deprivation with or without docetaxel chemotherapy, Abiraterone, Enzalutamide or any other proven agent) treatment as determined by treating physician (positive control).
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Ablative Therapy (MIAT)
Other Intervention Name(s)
Metastatic Directed Therapy (MDT)
Intervention Description
MIAT includes High intensity focused ultrasound (HIFU) or Cryotherapy to the prostate. Metastatic Directed Therapy available for use.
Intervention Type
Procedure
Intervention Name(s)
Radical Therapy (Prostatectomy or Radiotherapy)
Other Intervention Name(s)
Metastatic Directed Therapy (MDT)
Intervention Description
Radical therapy includes: Prostatectomy (any surgical approach) or External beam radiotherapy (High dose). Metastatic Directed Therapy available for use.
Primary Outcome Measure Information:
Title
Prostate cancer on post-standard of care prostate biopsy.
Description
Proportion of patients with complete pathological response, measured on post SOC (systemic therapy) prostate biopsies (Internal Pilot).
Time Frame
6 months
Title
Safety (Adverse Events)
Description
Safety (Adverse Events), measured using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Grade 1-5.
Time Frame
2-4 years (continuous)
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS), measured as a composite outcome of Biochemical failure (PSA progression value) or Local progression or Lymph node progression or Bone metastases progression (new sites) or Progression or development of new distant metastases, defined as lymph nodes outside the pelvis, bone or organ involvement or Skeletal-related events confirmed as progression as in the Systemic Therapy in Advancing Or Metastatic Prostate Cancer: Evaluation Of Drug Efficacy (STAMPEDE) RCT).
Time Frame
2-4 years
Secondary Outcome Measure Information:
Title
Urinary side effects
Description
Urinary side effects, measured using the IPSS questionnaire, Score 0-35.
Time Frame
Baseline, week 26, 52, then at 24 months.
Title
Sexual side effects
Description
Sexual side effects, measured using the IIEF15 questionnaire, Score 0-75.
Time Frame
Baseline, week 26, 52, then at 24 months.
Title
Rectal side effects
Description
Rectal side effects, measured using the EPIC bowel and bladder questionnaire, Score 14-113.
Time Frame
Baseline, week 26, 52, then at 24 months.
Title
Progression (Biochemical / Radiological / Clinical)
Description
Progression on PSA and imaging and impact of clinical features on progression, measured using PSA blood tests
Time Frame
Baseline, week 12, 26, 34, 52 then every every 24 weeks for remaining years 2 to 4 and Imaging tests at baseline and if progression is suspected by a clinician
Title
Health-related quality-of-life
Description
Health-related quality-of-life, measured using EuroQol (EQ-5D-5L) questionnaire, Score 0-100.
Time Frame
Baseline, week 26, 52, then at 24 months.

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with prostate cancer within 6 months of screening visit Metastatic disease (Any T, Any N, M1+) of any grade, stage or Prostate Specific Antigen (PSA) level. Fit to undergo standard of care treatment for metastatic disease and both minimally invasive therapy and prostate radiotherapy/prostatectomy. Performance status 0-2 Histologically proven local tumour Exclusion Criteria: 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 Xray (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. 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. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hashim U Ahmed, FRCS Urol
Phone
07517551949
Email
atlanta@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna T Sukumar, MSc
Phone
07517551949
Email
atlanta@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim U Ahmed, FRCS Urol
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wirral University Teaching Hospital, Wirral University Teaching Hospital NHS Foundation Trust
City
Birkenhead
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal Kumar
Email
manalkumar@nhs.net
First Name & Middle Initial & Last Name & Degree
Manal Kumar, FRCS
Facility Name
Glan Clwyd Hospital
City
Bodelwyddan
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Heron
Phone
01745448720
Ext
7656
Email
Jane.Heron@wales.nhs.uk
First Name & Middle Initial & Last Name & Degree
Nikhil Oommen, FRCS Urol
Facility Name
Darent Valley Hospital
City
Dartford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjeev Madaan
Email
sanjeev.madaan@nhs.net
First Name & Middle Initial & Last Name & Degree
Sanjeev Madaan, FRCS Urol
Facility Name
Royal Devon and Exeter NHS Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Piper
Email
jane.piper2@nhs.net
First Name & Middle Initial & Last Name & Degree
John McGrath, FRCS
Facility Name
Buckinghamshire Healthcare NHS Trust
City
High Wycombe
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Cserbane
Email
anita.cserbane@nhs.net
First Name & Middle Initial & Last Name & Degree
Neil Haldar, FRCS Urol
Facility Name
West Middlesex University Hospital
City
Isleworth
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Metod Oblak
Email
metod.oblak@nhs.net
First Name & Middle Initial & Last Name & Degree
Mathias Winkler, FRCS Urol
Facility Name
Queen Elizabeth Hospital, Kings Lynn
City
King's Lynn
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophy Shedwell
Email
Sophy.Shedwell@qehkl.nhs.uk
First Name & Middle Initial & Last Name & Degree
Gail Horan, FRCR
Facility Name
Chelsea and Westminster Hospital
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bijan Khoubehi
Email
bijan.khoubehi@chelwest.nhs.uk
First Name & Middle Initial & Last Name & Degree
Bijan Khoubehi, FRCS Urol
Facility Name
The Royal Marsden NHS Foundation Trust, Chelsea Research Centre
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Khoo
Email
Vincent.Khoo@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Vincent Khoo, FRCR
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hashim U Ahmed, FRCS Urol
First Name & Middle Initial & Last Name & Degree
Hashim U Ahmed, FRCS Urol
First Name & Middle Initial & Last Name & Degree
Martin J Connor, MRCS
First Name & Middle Initial & Last Name & Degree
Mathias Winkler, FRCS Urol
First Name & Middle Initial & Last Name & Degree
Taimur Shah, FRCS Urol
Facility Name
North Middlesex University Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgios Imseeh
Email
g.imseeh@nhs.net
First Name & Middle Initial & Last Name & Degree
Georgios Imseeh
Facility Name
Northwick Park, London North West Healthcare NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giles Hellawell, FRCS
Email
Giles.hellawell@nhs.net
First Name & Middle Initial & Last Name & Degree
Giles Hellawell, FRCS
Facility Name
St George's University Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hasan Qazi
Email
Hasan.Qazi2@stgeorges.nhs.uk
First Name & Middle Initial & Last Name & Degree
Hasan Qazi, MD FRCS Urol
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Mitra
Email
anita.mitra2@nhs.net
First Name & Middle Initial & Last Name & Degree
Anita Mitra
Facility Name
Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle
ZIP/Postal Code
NE7 7DM
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhavan Rai
Email
bhavan.rai@nhs.net
First Name & Middle Initial & Last Name & Degree
Bhavan Rai, FRCS Urol
Facility Name
Oxford University Hospital
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Pirkl
Email
martin.pirkl@nds.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Alastair Lamb, FRCS Urol
Facility Name
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Dudderidge
Email
Tim.Dudderidge@uhs.nhs.uk
First Name & Middle Initial & Last Name & Degree
Tim Dudderidge, FRCS Urol
Facility Name
Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Asterling
Email
sue.asterling@nhs.net
First Name & Middle Initial & Last Name & Degree
Stuart McCraken, FRCS Urol
Facility Name
Croydon University Hospital
City
Thornton Heath
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibiyemi Sadare
Phone
02084013000
Ext
4761
Email
ibiyemi.sadare@nhs.net
First Name & Middle Initial & Last Name & Degree
Babbin John, FRCS Urol
Facility Name
Southend University Hospital
City
Westcliff-on-Sea
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abd-Alazeez
Email
mohamed.abdalazeez@nhs.net
First Name & Middle Initial & Last Name & Degree
Mohamed Abd-Alazeez, FRCS Urol
Facility Name
Clatterbridge Cancer Centre
City
Wirral
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Beresford
Email
lucy.beresford@nhs.net
First Name & Middle Initial & Last Name & Degree
Azman Ibrahim, FRCR

12. IPD Sharing Statement

Citations:
PubMed Identifier
33632752
Citation
Connor MJ, Shah TT, Smigielska K, Day E, Sukumar J, Fiorentino F, Sarwar N, Gonzalez M, Falconer A, Klimowska-Nassar N, Evans M, Naismith OF, Thippu Jayaprakash K, Price D, Gayadeen S, Basak D, Horan G, McGrath J, Sheehan D, Kumar M, Ibrahim A, Brock C, Pearson RA, Anyamene N, Heath C, Shergill I, Rai B, Hellawell G, McCracken S, Khoubehi B, Mangar S, Khoo V, Dudderidge T, Staffurth JN, Winkler M, Ahmed HU. Additional Treatments to the Local tumour for metastatic prostate cancer-Assessment of Novel Treatment Algorithms (IP2-ATLANTA): protocol for a multicentre, phase II randomised controlled trial. BMJ Open. 2021 Feb 25;11(2):e042953. doi: 10.1136/bmjopen-2020-042953.
Results Reference
derived
Links:
URL
http://imperialprostate.org.uk/atlanta
Description
ATLANTA Clinical Trial Website

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Additional Treatments to the Local Tumour for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms

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