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

Study ID: 40854
Short Title: IP2 - ATLANTA
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: Urology
Phase: N/A
Expected End Date: 31/08/2024
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

1. Diagnosed with prostate cancer within 6 months of screening visit 2. Metastatic disease (Tany, Nany, M1+) 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 Embedded [68Ga]PSMA-11 PET sub study Patients must meet all the criteria listed in the main protocol and the following criteria for sub-study entry. Signed separate consent for participation in the ATLANTA PET Sub-study is required. Main Inclusion Criteria: 1. Confirmed newly diagnosed metastatic prostate cancer as per PCWG3 guidelines (MPC is defined as extrapelvic disease e.g. retroperitoneal, mediastinal, thoracic), who are due to start ST (physician directed). 2. Age > = 18 years 3. WHO performance status < = 2 4. Clinically acceptable full blood count, renal and liver function (as judged by the investigator)

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 3 months of randomisation. 3. Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above) Embedded [68Ga]PSMA-11 PET sub study: Main Exclusion Criteria 1. Metastatic prostate cancer patients who have had previous surgery and or radiotherapy treatment. 2. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.

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

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