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

NCT03763253 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 18HH4804
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 21

Brief Summary

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

Conditions

Prostate Cancer; Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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).

  6 months

• Safety (Adverse Events)

  Safety (Adverse Events), measured using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Grade 1-5.

  2-4 years (continuous)

• 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).

  2-4 years

Secondary Outcomes (5)

• Urinary side effects

  Baseline, week 26, 52, then at 24 months.

• Sexual side effects

  Baseline, week 26, 52, then at 24 months.

• Rectal side effects

  Baseline, week 26, 52, then at 24 months.

• Progression (Biochemical / Radiological / Clinical)

  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

• Health-related quality-of-life

  Baseline, week 26, 52, then at 24 months.

Study Arms (3)

Control Arm: Standard of Care (SOC)

ACTIVE COMPARATOR

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

Intervention Arm 1: Minimally Invasive Ablative Therapy (MIAT)

ACTIVE COMPARATOR

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; Procedure: Minimally Invasive Ablative Therapy (MIAT)

Intervention Arm 2: Radical Therapy

ACTIVE COMPARATOR

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; Procedure: Radical Therapy (Prostatectomy or Radiotherapy)

Interventions

Standard of Care COMBINATION_PRODUCT

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

Control Arm: Standard of Care (SOC); Intervention Arm 1: Minimally Invasive Ablative Therapy (MIAT); Intervention Arm 2: Radical Therapy

Minimally Invasive Ablative Therapy (MIAT) PROCEDURE

MIAT includes High intensity focused ultrasound (HIFU) or Cryotherapy to the prostate. Metastatic Directed Therapy available for use.

Also known as: Metastatic Directed Therapy (MDT)

Intervention Arm 1: Minimally Invasive Ablative Therapy (MIAT)

Radical Therapy (Prostatectomy or Radiotherapy) PROCEDURE

Radical therapy includes: Prostatectomy (any surgical approach) or External beam radiotherapy (High dose). Metastatic Directed Therapy available for use.

Also known as: Metastatic Directed Therapy (MDT)

Intervention Arm 2: Radical Therapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College London: lead
• Wellcome Trust: collaborator

Study Sites (21)

Wirral University Teaching Hospital, Wirral University Teaching Hospital NHS Foundation Trust

Birkenhead, CH49 5PE, United Kingdom

Location

Glan Clwyd Hospital

Bodelwyddan, LL18 5UJ, United Kingdom

Location

Darent Valley Hospital

Dartford, United Kingdom

Location

Royal Devon and Exeter NHS Trust

Exeter, EX2 5DW, United Kingdom

Location

Buckinghamshire Healthcare NHS Trust

High Wycombe, United Kingdom

Location

West Middlesex University Hospital

Isleworth, TW7 6AF, United Kingdom

Location

Queen Elizabeth Hospital, Kings Lynn

Kings Lynn, PE30 4ET, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

The Royal Marsden NHS Foundation Trust, Chelsea Research Centre

London, SW3 6JJ, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

Location

North Middlesex University Hospital

London, United Kingdom

Location

Northwick Park, London North West Healthcare NHS Trust

London, United Kingdom

Location

St George's University Hospital

London, United Kingdom

Location

University College London Hospital

London, United Kingdom

Location

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Location

Freeman Hospital, Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE7 7DM, United Kingdom

Location

Oxford University Hospital

Oxford, United Kingdom

Location

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust (UHS)

Southampton, SO16 6YD, United Kingdom

Location

Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust

Sunderland, SR4 7TP, United Kingdom

Location

Croydon University Hospital

Thornton Heath, CR7 7YE, United Kingdom

Location

Southend University Hospital

Westcliff-on-Sea, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33632752 DERIVED

Related Links

• ATLANTA Clinical Trial Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care; Prostatectomy; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Therapeutics

Study Officials

• Hashim U Ahmed, FRCS Urol

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm unblinded randomised controlled trial using a positive control

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 4, 2018
• Study Start: April 10, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

GB (21)