Surgical treatment with or without apalutamide in subjects with high risk prostate cancer who are candidates for radical prostatectomy and staged as oligometastatic with PSMA-PET (STAPLE)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515049-41-00

Enrollment

Registered

2024-08-13

Start date

2024-07-12

Completion date

Unknown

Last updated

2026-01-08

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

Conditions

metastatic prostate cancer

Brief summary

Radiological progression-free survival (RPFS), evaluated based on PSMA PET/CT

Detailed description

Adverse events (AEs), Biochemical progression-free survival (BPFS)* Progression-free survival 2 (PFS2) Time to castration-resistant PCa (CRPC) Percentage of subjects receiving postoperative radiotherapy Overall survival (OS), Change from baseline over time in Expanded Prostate Cancer Index (EPIC-26) and EQ-5D-5L

Interventions

DRUGErleada 60 mg film-coated tablets

DRUGAPALUTAMIDE

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Radiological progression-free survival (RPFS), evaluated based on PSMA PET/CT	—

Secondary

Measure	Time frame
Adverse events (AEs), Biochemical progression-free survival (BPFS)* Progression-free survival 2 (PFS2) Time to castration-resistant PCa (CRPC) Percentage of subjects receiving postoperative radiotherapy Overall survival (OS), Change from baseline over time in Expanded Prostate Cancer Index (EPIC-26) and EQ-5D-5L	—

Countries

Italy

Outcome results

None listed

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