Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer

Study acronym: RAPSON
StatusUnknown
PhasePhase 2
Started

Record status This record was last updated September 27, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria expanded, about 21 words
    • Site details revised at 15 of 15 sites
    v7
  3. Site details revised at 9 of 15 sitesv6
  4. Primary completion date: Aug 2021 to Jul 2025
    • Study sites: 12 to 15
    • Study completion date: Aug 2022 to Jul 2025
    • Collaborators expanded, about 1 word
    v5
  5. Primary completion date: Aug 2019 to Aug 2021
    • Study sites: 9 to 12
    • Study completion date: Aug 2020 to Aug 2022
    • Secondary endpoints revised (5)
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2017 to Sep 1, 2017
    • Site details revised at 9 of 9 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) Open-label, randomized phase II trial in patients with symptomatic bone-only metastatic castration-resistant prostate cancer. Eligible patients are randomly assigned into two arms: * Arm A: radium-223 initially followed by docetaxel plus prednisone at the time of progression (the second step is optional according to clinical evolution of disease) * Arm B: docetaxel plus prednisone initially followed by radium-223 at the time of progression (the second step is optional according to clinical evolution of disease).
Trial Details
NCT Number NCT03230734
Lead Sponsor Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Collaborators: Bayer
Conditions
(from sponsor)		 Metastatic Castration-resistant Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov