IP2 - ATLANTA

• Research type

  Research Study

• Full title

  ATLANTA - Adjuvant Treatments to the Local tumour for metastatic prostate cancer: Assessment of Novel Treatment Algorithms

• IRAS ID

  246081

• Contact name

  Hashim U. Ahmed

• Contact email

  hashim.ahmed@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• ISRCTN Number

  ISRCTN58401737

• Clinicaltrials.gov Identifier

  NCT03763253

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  Men diagnosed with prostate cancer that has spread to other organs are currently treated with drug therapy alone usually androgen deprivation therapy (ADT). ADT suppresses the male hormone, testosterone, which the prostate cells need to grow.Some men also have chemotherapy with ADT

  Recent evidence shows treating the main cancer in the prostate itself might prolong the time ADT control the cancer and might improve survival.Treatment directed to the metastases has also shown some initial promising data.There are no randomised controlled trials (RCT) that have shown this yet so we need better evidence to see if local treatment to the prostate might be beneficial in combination with treatment to metastases in some men. This is important since local radical therapy(surgery or radiotherapy)can have side-effects.Ablation therapy using heating or freezing has shown to have lower side-effects when used in men whose cancer has not spread so might be a alternative to radical therapy in men with metastatic cancer.

  Eligible men will be asked to participate in a RCT comparing standard drug therapy to radical therapy (surgery or radiotherapy) or local ablation (heating or freezing) therapy,in combination with metastases directed therapy in select men.

  80 men will be approached in 10 UK centre to estimate recruitment rate, acceptability of the trial randomisation, reported toxicities and adherence to trial interventions in a pilot phase. They will also be included into the Main phase where 918 will be recruited. Participants will remain in the study for a maximum of 4 years. Our aims are to see whether men will participate in this trial (pilot) before we continue to run a larger trial (Main), and the impact of these treatments on quality of life.

  [68Ga]PSMA-11 PET-CT substudy:
  Embedded within the pilot phase this sub-study assesses the role of [68Ga]PSMA-11 PET in metastatic prostate cancer as this unknown.Blood and urine taken from patients will establish prognostic & predictive factors

• REC name

  Wales REC 5

• REC reference

  19/WA/0005

• Date of REC Opinion

  22 Jan 2019

• REC opinion

  Favourable Opinion