Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763253
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
Local cytoreductive treatments for men with newly diagnosed metastatic prostate cancer in addition to standard of care treatment

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Prostate Cancer Combination Product: Standard of Care Procedure: Minimally Invasive Ablative Therapy (MIAT) Procedure: Radical Therapy (Prostatectomy or Radiotherapy) Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 918 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Three-arm unblinded randomised controlled trial using a positive control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Cytoreductive Treatments for Men With Newly Diagnosed Metastatic Prostate Cancer in Addition to Standard of Care Treatment
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Control Arm: Standard of Care (SOC)

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.

Combination Product: Standard of Care
Androgen deprivation with or without docetaxel chemotherapy, Abiraterone, Enzalutamide or any other proven agent) treatment as determined by treating physician (positive control).

Active Comparator: Intervention Arm 1: Minimally Invasive Ablative Therapy (MIAT)

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).

Combination Product: Standard of Care
Androgen deprivation with or without docetaxel chemotherapy, Abiraterone, Enzalutamide or any other proven agent) treatment as determined by treating physician (positive control).

Procedure: Minimally Invasive Ablative Therapy (MIAT)

MIAT includes High intensity focused ultrasound (HIFU) or Cryotherapy to the prostate.

Metastatic Directed Therapy available for use.

Other Name: Metastatic Directed Therapy (MDT)

Active Comparator: Intervention Arm 2: Radical Therapy

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).

Combination Product: Standard of Care
Androgen deprivation with or without docetaxel chemotherapy, Abiraterone, Enzalutamide or any other proven agent) treatment as determined by treating physician (positive control).

Procedure: Radical Therapy (Prostatectomy or Radiotherapy)

Radical therapy includes: Prostatectomy (any surgical approach) or External beam radiotherapy (High dose).

Metastatic Directed Therapy available for use.

Other Name: Metastatic Directed Therapy (MDT)




Primary Outcome Measures :
  1. Prostate cancer on post-standard of care prostate biopsy. [ Time Frame: 6 months ]
    Proportion of patients with complete pathological response, measured on post SOC (systemic therapy) prostate biopsies (Internal Pilot).

  2. Safety (Adverse Events) [ Time Frame: 2-4 years (continuous) ]
    Safety (Adverse Events), measured using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Grade 1-5.

  3. Progression-free survival (PFS) [ Time Frame: 2-4 years ]
    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 :
  1. Urinary side effects [ Time Frame: Baseline, week 26, 52, then at 24 months. ]
    Urinary side effects, measured using the IPSS questionnaire, Score 0-35.

  2. Sexual side effects [ Time Frame: Baseline, week 26, 52, then at 24 months. ]
    Sexual side effects, measured using the IIEF15 questionnaire, Score 0-75.

  3. Rectal side effects [ Time Frame: Baseline, week 26, 52, then at 24 months. ]
    Rectal side effects, measured using the EPIC bowel and bladder questionnaire, Score 14-113.

  4. Progression (Biochemical / Radiological / Clinical) [ 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 ]
    Progression on PSA and imaging and impact of clinical features on progression, measured using PSA blood tests

  5. Health-related quality-of-life [ Time Frame: Baseline, week 26, 52, then at 24 months. ]
    Health-related quality-of-life, measured using EuroQol (EQ-5D-5L) questionnaire, Score 0-100.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763253


Contacts
Layout table for location contacts
Contact: Martin J Connor, MBBS, BSc (Hons), MSc, MRCS 02033115473 atlanta@imperial.ac.uk
Contact: Johanna T Sukumar, BSc, MSc 02033115473 atlanta@imperial.ac.uk

Locations
Layout table for location information
United Kingdom
Wexham Park Hospital, Frimley Health NHS Foundation Trust Not yet recruiting
Frimley, Surrey, United Kingdom, GUI16 7UJ
Contact: Marc Laniado       marc.laniado@nhs.net   
Principal Investigator: Marc Laniado         
The Royal United Hospital, Royal United Hospitals Bath NHS Foundation Trust Not yet recruiting
Bath, United Kingdom, BA1 3NG
Contact: Jaspal S Phull, FRCS(Urol)    01225 824573    jaspal.phull1@nhs.net   
Principal Investigator: Jaspal S Phull, FRCS(Urol)         
Wirral University Teaching Hospital, Wirral University Teaching Hospital NHS Foundation Trust Recruiting
Birkenhead, United Kingdom, CH49 5PE
Contact: Manal Kumar, MBBS MS MSh FRCS ED         
Principal Investigator: Manal Kumar, MBBS MS MSh FRCS ED         
Royal Devon and Exeter NHS Trust Recruiting
Exeter, United Kingdom, EX2 5DW
Contact: John McGrath, BMedSci BMBS FRCS         
Principal Investigator: John McGrath, BMedSci BMBS FRCS         
West Middlesex University Hospital Recruiting
Isleworth, United Kingdom, TW7 6AF
Contact: Mathias Winkler, MBBS BSc MD FRCS (Urol)         
Principal Investigator: Mathias Winkler, MBBS BSc MD FRCS (Urol         
Queen Elizabeth Hospital, Kings Lynn Recruiting
King's Lynn, United Kingdom, PE30 4ET
Contact: Gail Horan, MRCPI, FRCR         
Principal Investigator: Gail Horan, MRCPI, FRCR         
Guy's and St Thomas Hospital, Guy's and St Thomas' NHS Foundation Trust Not yet recruiting
London, United Kingdom, SE1 7EH
Contact: Paul Cathcart, FRCS (Urol)         
Principal Investigator: Paul Cathcart, FRCS (Urol)         
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9NH
Contact: Bijan Khoubehi, FRCS(Urol)         
Principal Investigator: Bijan Khoubehi, FRCS(Urol)         
The Royal Marsden NHS Foundation Trust, Chelsea Research Centre Not yet recruiting
London, United Kingdom, SW3 6JJ
Contact: Vincent Khoo       Vincent.Khoo@rmh.nhs.uk   
Principal Investigator: Vincent Khoo         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W6 8RF
Contact: Hashim U Ahmed, BM, BCh (Oxon), BA, PhD, FRCS         
Principal Investigator: Hashim U Ahmed, BM, BCh (Oxon), BA, PhD, FRCS         
Sub-Investigator: Martin J Connor, MBBS, BSc (Hons), MSc, MRCS         
Sub-Investigator: Mathias Winkler, MD, FRCS (Urol)         
Sub-Investigator: John Staffurth, MD, FRCP, FRCR         
Sub-Investigator: Alison Falconer, MA, MRCP, FRCR         
Sub-Investigator: Suraiya Dubash, MBBS, BSc, MRCP, FRCR         
Northwick Park, London North West Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Giles Hellawell, MA BM BCH FRCS         
Principal Investigator: Giles Hellawell, MA BM BCH FRCS         
Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust Active, not recruiting
Newcastle, United Kingdom, NE7 7DM
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS) Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Tim Dudderidge, FRCS (Urol)         
Principal Investigator: Tim Dudderidge, FRCS (Urol)         
Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust Recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Stuart McCracken, FRCS (Urol)         
Principal Investigator: Stuart McCraken, FRCS (Urol)         
Worcestershire Acute Hospitals NHS Trust Not yet recruiting
Worcester, United Kingdom, WR5 1DD
Contact: Adel Makar       a.makar@nhs.net   
Principal Investigator: Adel Makar         
Sponsors and Collaborators
Imperial College London
Wellcome Trust
Investigators
Layout table for investigator information
Principal Investigator: Hashim U Ahmed, BM, BCh (Oxon), BA, PhD, FRCS Imperial College London
Additional Information:
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03763253    
Other Study ID Numbers: 18HH4804
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases