Additional Treatments to the Local Tumour for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms (IP2-ATLANTA)
Prostate Cancer, Metastatic Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer
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 4 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)
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
Active Comparator
Active Comparator
Active Comparator
Control Arm: Standard of Care (SOC)
Intervention Arm 1: Minimally Invasive Ablative Therapy (MIAT)
Intervention Arm 2: Radical Therapy
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).