{"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":[],"indication":"newly diagnosed metastatic prostate cancer","name":"SIMCAP","nct_id":"NCT03456843","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=simcap-nct03456843. 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":null,"arms":[{"description":"BST - to be determined by the treating physician. Currently, BST is permanent ADT +/- docetaxel (1-3). In patients who were treated with ADT ≥ 1 month prior to randomization, docetaxel, if chosen by the provided, will be given as soon as feasible. In men not treated with ADT or for a duration less than or equal to one month prior to randomization, ADT will be given for a minimum of one month prior to docetaxel therapy. All forms of ADT are allowed. The regimen will be at the discretion of the treating physician. Docetaxel regimen will be at the discretion of the provider. At the time of disease progression, the patient will come off the study treatment phase and enter into follow up. The next line of therapy will be at the discretion of the provider.","label":"Arm I (Control Group)","type":"EXPERIMENTAL"},{"description":"CRP+BST. Patients will undergo surgery if the duration of ADT is greater than one month prior to surgery. In men who have not been treated with ADT or received ADT less than or equal to one month prior to entering the study, ADT will be initiated or continued to ensure that the patients have been treated with ADT for at least one month prior to CRP. Docetaxel must be administered, if selected, prior to surgery. Following surgery, ADT will be continued. Although the surgical approach is at the discretion of the surgeon, robot assistance is the preferred primary approach. At the time of disease progression, the patient will come off the study treatment phase and enter into follow up. The next line of therapy will be at the discretion of the provider.","label":"Arm II (Experimental)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2027-03","type":"ESTIMATED"},"conditions":["Stage IV Prostate Adenocarcinoma AJCC v7"],"enrollment":{"count":190,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Antiandrogen Therapy","otherNames":["ADT","Androgen Deprivation Therapy","Anti-androgen Therapy","Anti-androgen Treatment","Antiandrogen Treatment","Hormone Deprivation Therapy","Hormone-Deprivation Therapy"],"type":"DRUG"},{"name":"Docetaxel","otherNames":["Docecad","RP56976","Taxotere","Taxotere Injection Concentrate"],"type":"DRUG"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"PROCEDURE"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"},{"name":"Radical Prostatectomy","otherNames":["Prostatovesiculectomy"],"type":"PROCEDURE"}],"last_update":"2026-07-24","lead_sponsor":"Yale University","official_title":"SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed Metastatic Prostate Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-03","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Failure-free survival (FFS)","timeFrame":"At 2 years"}],"references":[],"start_date":{"date":"2018-03-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT03456843"},"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/simcap-nct03456843"}