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Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment

Study acronym: APPROACH
StatusRecruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Jan 30, 2024, no change to tracked fieldsv5-v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2023 to Mar 1, 2023
    • Site details revised at 3 of 3 sites
    v4
  3. Start date: Feb 2, 2023 to Feb 1, 2023
    • Eligibility criteria shortened, about 17 words
    v3
  4. Start date: Jan 2, 2023 to Feb 2, 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Italian multicenter study, will enroll \~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide. After 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.
Trial Details
NCT Number NCT05649943
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators: ASST Santi Paolo e Carlo, European Institute of Oncology
Conditions
(from sponsor)		 Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Enrollment 566 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov