{"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":"PRIME","nct_id":"NCT03561961","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=prime-nct03561961. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"PRIME","arms":[{"description":"In arm 1 of the study, patients who are randomized to receive moderately hypo-fractionated RT will receive a total dose of 66-68 Gy in 25# to the primary over 5 weeks, with treatment being delivered daily. All patients will receive a dose of 50 Gy in 25# to the pelvis. Boost to gross nodal disease will be considered based on the response to hormonal therapy to a dose of 60-66 Gy/25# as a simultaneous integrated boost(SIB).","label":"Moderate Hypo-fractionation","type":"ACTIVE_COMPARATOR"},{"description":"In Arm 2 of the study, patients who are scheduled to receive SBRT will receive a course of 5 fractions of radiation; each fraction size will be 7.00-7.25 Gy. The total dose will be 35-36.5 Gy. All patients will receive a dose of 25 Gy in 5 # to the pelvis. Boost to gross nodal disease will be considered based on the response to hormonal therapy to a dose of 30-35 Gy/5# as a simultaneous integrated boost(SIB).The 5 treatments will be scheduled to be delivered alternate day over approximately 7-10 days. An option of equivalent biological dose using 35-36.5 Gy in 5 weekly fractions may be allowed for multicentric accrual in the future.","label":"Extreme Hypo-fractionation","type":"EXPERIMENTAL"}],"collaborators":["Tata Medical Center"],"completion_date":{"date":"2035-03","type":"ESTIMATED"},"conditions":["Prostate Adenocarcinoma"],"enrollment":{"count":526,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Moderate Hypo-fractionation","otherNames":[],"type":"RADIATION"},{"name":"Extreme Hypo-fractionation","otherNames":["SBRT"],"type":"RADIATION"}],"last_update":"2025-02-13","lead_sponsor":"Tata Memorial Centre","official_title":"Randomised Controlled Trial of Prostate Radiotherapy In High Risk and Node Positive Disease Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["NA"],"primary_completion_date":{"date":"2024-09-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Biochemical Failure free Survival (BFFS)","timeFrame":"5 years"}],"references":[{"citation":"Murthy V, Mallick I, Gavarraju A, Sinha S, Krishnatry R, Telkhade T, Moses A, Kannan S, Prakash G, Pal M, Menon S, Popat P, Rangarajan V, Agarwal A, Kulkarni S, Bakshi G. Study protocol of a randomised controlled trial of prostate radiotherapy in high-risk and node-positive disease comparing moderate and extreme hypofractionation (PRIME TRIAL). BMJ Open. 2020 Feb 28;10(2):e034623. doi: 10.1136/bmjopen-2019-034623.","pmid":"32114475","type":"BACKGROUND"},{"citation":"Murthy V, Gulati S, Ghosh S, Sable S, Phurailatpam R, Patil D, Mhatre R, Chougle N, Solanki M, Singh M, Verma P, Singh P, Maitre P. Empty-RT: A Phase 2 Trial of Prostate Stereotactic Body Radiation Therapy With an Empty Bladder Approach. Int J Radiat Oncol Biol Phys. 2026 Jul 31:S0360-3016(26)04064-2. doi: 10.1016/j.ijrobp.2026.07.018. Online ahead of print.","pmid":"42537851","type":"DERIVED"}],"start_date":{"date":"2018-05-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Prostate Radiotherapy Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)","url":"https://clinicaltrials.gov/study/NCT03561961"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/prime-nct03561961"}