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Standard dosed abiraterone versus Therapeutic Drug Monitoring guided abiraterone dosing – The Adapt Abi trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524440-35-00
Enrollment
230
Registered
2026-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic castration resistant prostate cancer (mCRPC)

Brief summary

Radiographic progression-free survival (PFS)

Detailed description

Feasibility and safety of TDM, Physician adherence to TDM advice, Clinical progression, Overall response rates (ORR), Prostate Specific Antigen response rate (PSArr), PSA response at 12 weeks, Maximal PSA response, Time to PSA progression, Time on treatment (ToT), Overall survival (OS), Quality of life (QoL), Cost-effectiveness, Patient adherence, Toxicity (also in relationship to abiraterone concentrations and dose interventions)

Interventions

DRUGAbirateron Sandoz 500 mg
DRUGfilmomhulde tabletten

Sponsors

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Radiographic progression-free survival (PFS)—

Secondary

MeasureTime frame
Feasibility and safety of TDM, Physician adherence to TDM advice, Clinical progression, Overall response rates (ORR), Prostate Specific Antigen response rate (PSArr), PSA response at 12 weeks, Maximal PSA response, Time to PSA progression, Time on treatment (ToT), Overall survival (OS), Quality of life (QoL), Cost-effectiveness, Patient adherence, Toxicity (also in relationship to abiraterone concentrations and dose interventions)—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 8, 2026