{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"IP2-ATLANTA","nct_id":"NCT03763253","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ip2-atlanta-nct03763253. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"IP2-ATLANTA","arms":[{"description":"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).\n\nRadiotherapy 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).\n\nMetastases 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.","label":"Control Arm: Standard of Care (SOC)","type":"ACTIVE_COMPARATOR"},{"description":"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.\n\nMetastatic directed therapy will be available for use in this arm (if declared at randomisation).","label":"Intervention Arm 1: Minimally Invasive Ablative Therapy (MIAT)","type":"ACTIVE_COMPARATOR"},{"description":"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.\n\nFor patients undergoing radical prostatectomy no local prostate radiotherapy will be given as part of the intervention. Radiotherapy can be given subsequently for palliative reasons.\n\nRadical radiotherapy doses in this arm will be higher than SOC.\n\nMetastatic directed therapy will be available for use in this arm (if declared at randomisation).","label":"Intervention Arm 2: Radical Therapy","type":"ACTIVE_COMPARATOR"}],"collaborators":["Wellcome Trust"],"completion_date":{"date":"2027-01-31","type":"ESTIMATED"},"conditions":["Prostate Cancer","Metastatic Prostate Cancer"],"enrollment":{"count":433,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Standard of Care","otherNames":[],"type":"COMBINATION_PRODUCT"},{"name":"Minimally Invasive Ablative Therapy (MIAT)","otherNames":["Metastatic Directed Therapy (MDT)"],"type":"PROCEDURE"},{"name":"Radical Therapy (Prostatectomy or Radiotherapy)","otherNames":["Metastatic Directed Therapy (MDT)"],"type":"PROCEDURE"}],"last_update":"2025-02-07","lead_sponsor":"Imperial College London","official_title":"Local Cytoreductive Treatments for Men With Newly Diagnosed Metastatic Prostate Cancer in Addition to Standard of Care Treatment","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-08-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Prostate cancer on post-standard of care prostate biopsy.","timeFrame":"6 months"},{"measure":"Safety (Adverse Events)","timeFrame":"2-4 years (continuous)"},{"measure":"Progression-free survival (PFS)","timeFrame":"2-4 years"}],"references":[{"citation":"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","type":"DERIVED"}],"start_date":{"date":"2019-04-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Additional Treatments to the Local Tumour for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms","url":"https://clinicaltrials.gov/study/NCT03763253"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ip2-atlanta-nct03763253"}