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A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer

Study acronym: ASCLEPIuS
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Nov 2026 to May 2027
    • Study completion date: May 2027 to May 2029
    v14
  2. Re-verified, no change to tracked fieldsv13
  3. Eligibility criteria revisedv12
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 102
    • Site details revised at 6 of 6 sites
    v11
  5. Study sites: 4 to 6v10
Show 8 earlier versionsHide 8 earlier versions
  1. Eligibility criteria expanded, about 3 wordsv9
  2. Study sites: 3 to 4v8
  3. Study sites: 1 to 3v7
  4. Primary completion date: Dec 2026 to Nov 2026
    • Study completion date: Jun 2027 to May 2027
    • Start date changed from estimate of Dec 2020 to Nov 6, 2020
    v6
  5. Start date: Aug 2020 to Dec 2020
    • Primary completion date: Aug 2026 to Dec 2026
    • Study completion date: Feb 2027 to Jun 2027
    v5
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  7. Start date: May 2020 to Aug 2020
    • Primary completion date: May 2026 to Aug 2026
    • Study completion date: Nov 2026 to Feb 2027
    v3
  8. Start date: Mar 2020 to May 2020
    • Primary completion date: Mar 2026 to May 2026
    • Study completion date: Sep 2026 to Nov 2026
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (the phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (the phase 2 portion of the study).
Trial Details
NCT Number NCT04194554
Lead Sponsor University of Michigan Rogel Cancer Center
Collaborators: Janssen Scientific Affairs, LLC
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov