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Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed)

Study acronym: PROceed
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Final enrollment: 111 participants (planned 250) · Study sites: 34 to 36 · Eligibility criteria expanded, about 6 words · 2 more Show 5 more changesShow less
    • Final enrollment: 111 participants (planned 250)
    • Study sites: 34 to 36
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Collaborators: details revised at 1 of 1 entry
  2. Primary and study completion dates: Jan 31, 2027 to Feb 14, 2027v18
  3. 6 versions Re-verified since Jul 11, 2025, no change to tracked fieldsv12-v17
  4. Site details revised at 6 of 34 sitesv11
  5. Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 33 to 34v9
  2. Study sites: 31 to 33v8
  3. Study sites: 30 to 31v7
  4. Study sites: 28 to 30v6
  5. Site details revised at 7 of 28 sitesv5
  6. Study sites: 26 to 28v4
  7. Study sites: 14 to 26v3
  8. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AstraZeneca
727 trials monitored
See 61 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.
Trial Details
NCT Number NCT06380738
Lead Sponsor AstraZeneca
Collaborators: Merck Sharp & Dohme LLC
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov