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Clinical Trial Summary

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


Clinical Trial Description

TITLE: Adjuvant 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: 918

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.

*SOC may be initiated prior to recruitment and includes but is not limited to ADT alone, chemotherapy and/or newer hormonal agents. 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.

EMBEDDED STUDY: [68Ga] PSMA-11 PET-CT substudy. We will also ask men in the pilot part of ATLANTA if they are willing to undergo a PSMA PET scan. We 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.

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03763253
Study type Interventional
Source Imperial College London
Contact Martin J Connor, MBBS, BSc (Hons), MSc, MRCS
Phone 02033115473
Email atlanta@imperial.ac.uk
Status Not yet recruiting
Phase Phase 2
Start date January 1, 2019
Completion date March 1, 2024

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