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NCT05393791: ANZadapt

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

Recruiting now Phase 2 Last updated 26 November 2024
What this trial tests

Phase 2 trial testing Patient-specific adaptive therapy in Prostatic Neoplasms, Castration-Resistant in 168 participants. Currently enrolling.

Timeline
10 November 2022
Primary endpoint
10 November 2027
10 November 2027

Quick facts

Lead sponsorLeiden University Medical Center
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment168
Start date10 November 2022
Primary completion10 November 2027
Estimated completion10 November 2027
Sites19 locations across Netherlands, Australia

Drugs / interventions tested

Conditions studied

Sponsor

Leiden University Medical Center

Who can join

18 and older, male only, with Prostatic Neoplasms, Castration-Resistant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A survey of open questions in adaptive therapy: Bridging mathematics and clinical translation.
    West J, Adler F, Gallaher J, Strobl M, et al · · 2023 · cited 51× · PMID 36952376 · DOI 10.7554/elife.84263
  2. Treatment of evolving cancers will require dynamic decision support.
    Strobl MAR, Gallaher J, Robertson-Tessi M, West J, et al · · 2023 · cited 48× · PMID 37777307 · DOI 10.1016/j.annonc.2023.08.008
  3. Mathematical Model-Driven Deep Learning Enables Personalized Adaptive Therapy.
    Gallagher K, Strobl MAR, Park DS, Spoendlin FC, et al · · 2024 · cited 45× · PMID 38569183 · DOI 10.1158/0008-5472.can-23-2040
  4. Adaptive Cancer Therapy in the Age of Generative Artificial Intelligence.
    Derbal Y. · · 2024 · cited 7× · PMID 38897721 · DOI 10.1177/10732748241264704
  5. Stackelberg Evolutionary Games of Cancer Treatment: What Treatment Strategy to Choose if Cancer Can be Stabilized?
    Salvioli M, Garjani H, Satouri M, Broom M, et al · · 2025 · cited 4× · PMID 41140641 · DOI 10.1007/s13235-024-00609-z
  6. Mathematical Oncology: How Modeling Is Transforming Clinical Decision-Making.
    Scibilia KR, Gallagher K, Masud MA, Robertson-Tessi M, et al · · 2025 · cited 3× · PMID 41105675 · DOI 10.1158/0008-5472.can-25-0750
  7. Bringing evolutionary cancer therapy to the clinic: a systems approach.
    Soboleva A, Grossmann I, Dingemans AC, Rezaei J, et al · · 2025 · cited 3× · PMID 40425536 · DOI 10.1038/s41540-025-00528-8
  8. Adaptive cancer therapy: can non-genetic factors become its achilles heel?
    Valcz G, Gatenby RA, Újvári B, Buzás EI, et al · · 2025 · cited 2× · PMID 40983635 · DOI 10.1038/s41388-025-03582-y

Verify or expand the search:

Other recruiting trials for Prostatic Neoplasms, Castration-Resistant

Currently open trials in the same condition.

Other Leiden University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05393791.

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