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Apa/Enza short study (Shortened 12 months duration of androgen receptor signalling agent in combination with androgen deprivation therapy in patients with low-volume metastatic castration-sensitive prostate cancer: a randomized nationwide trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506698-36-00
Enrollment
400
Registered
2023-12-12
Start date
2024-02-02
Completion date
Unknown
Last updated
2025-12-03

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

Conditions

low-volume metastatic castration-sensitive prostate cancer

Brief summary

Time to clinical progression free survival (cPFS) in both arms

Detailed description

Overall survival (OS), Time to PSA increase (defined according to PCWG3 criteria), Time to first line therapy for mCRPC, ctDNA levels correlation with PSA levels, Value of ctDNA quantification during ARSI treatment to predict tumor progression, Quality of life (QoL) in relation to treatment with ARSI, To correlate PSMA-PET scan results to clinical outcomes, Correlation of genomic profiles of previously taken prostate cancer tissue biopsies and clinical outcome., Predict patients who will need continued ARSI treatment with ctDNA levels

Interventions

DRUGSuprefact Depot 9
DRUG45 mg implantat
DRUGPamorelin 11
DRUG25 mg
DRUGpoeder en oplosmiddel voor suspensie voor injectie
DRUGmet verlengde afgifte.
DRUGPamorelin 22
DRUG5 mg
DRUGPamorelin 3
DRUG75 mg
DRUGEligard 45 mg poeder en oplosmiddel voor oplossing voor injectie
DRUGLEUPRORELIN ACETATE
DRUGCAMCEVI 42 mg prolonged-release suspension for injection
DRUGGonapeptyl Depot 3
DRUG75 mg poeder en oplosmiddel voor suspensie voor injectie
DRUGEligard 22
DRUG5 mg poeder en oplosmiddel voor oplossing voor injectie
DRUGAPALUTAMIDE
DRUGELIGARD 7.5 mg powder and solvent for solution for injection
DRUGGOSERELIN ACETATE
DRUGLeuproreline Sandoz depot 3 maanden 5 mg
DRUGimplantaat
DRUGENZALUTAMIDE
DRUGDecapeptyl-CR 3

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to clinical progression free survival (cPFS) in both arms—

Secondary

MeasureTime frame
Overall survival (OS), Time to PSA increase (defined according to PCWG3 criteria), Time to first line therapy for mCRPC, ctDNA levels correlation with PSA levels, Value of ctDNA quantification during ARSI treatment to predict tumor progression, Quality of life (QoL) in relation to treatment with ARSI, To correlate PSMA-PET scan results to clinical outcomes, Correlation of genomic profiles of previously taken prostate cancer tissue biopsies and clinical outcome., Predict patients who will need continued ARSI treatment with ctDNA levels—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026