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Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC

Study acronym: ANZadapt
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 15 to 19 Eligibility criteria revisedv5 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 7 to 15v4
  3. Lead sponsor: dr. Tom van der Hulle to Leiden University Medical Center Study sites: 1 to 7 · Eligibility criteria expanded, about 19 words · Secondary endpoints revised (8) · 3 morev3 Show 6 more changesShow less
    • Study sites: 1 to 7
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 332 words
    • Collaborators reordered
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 1, 2022 to Nov 10, 2022 · Primary and study completion dates: Aug 1, 2027 to Nov 10, 2027 · Site details revisedv2 Show 3 more changesShow less
    • Start date changed from estimate of Aug 1, 2022 to Nov 10, 2022
    • Primary and study completion dates: Aug 1, 2027 to Nov 10, 2027
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Hormone tablets, abiraterone (Zytiga®) and enzalutamide (Xtandi®) are approved to treat advanced prostate cancer. However, even if these drugs are helpful, their effectiveness usually diminishes over time. Small pilot studies have indicated that using hormone tablets sparingly, for just long enough to control the cancer, followed by a break in treatment and restarting them later, seems to improve how long hormone tablets can control the cancer. This study aims to find out if this pause/restart strategy is better than taking hormone tablets every day continuously. The study will include 168 people with metastatic castrate resistant prostate cancer in the Netherlands and Australia. Patients will be randomly 1:1 assigned between the control group and the experimental group. In the control group, patients will take the treatment with AA/ENZ every day until the prostate cancer doesn't respond anymore to the treatment. In the experimental group, patients will start with daily AA/ENZ until the PSA has declined for \>50%. The treatment will then be paused and monthly PSA measurements will be performed. The treatment will be re-initiated when the PSA has increased to the level of before starting treatment. The treatment will be continued daily until the PSA has again dropped for \>50%. This pause/restart cycle will be repeated until the prostate cancer doesn't respond anymore to the treatment.
Trial Details
NCT Number NCT05393791
Lead Sponsor Leiden University Medical Center
Collaborators: Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Anticancer Fund, Belgium
Conditions Prostatic Neoplasms, Castration-Resistant
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov