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Phase III Randomized, International, Open-Label Clinical Trial of Treatment Intensification with Docetaxel plus Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment with Apalutamide: REINFORCE Trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524408-30-01
Enrollment
184
Registered
2026-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-20

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

Conditions

Metastatic hormone-sensitive prostate cancer

Brief summary

Event-free Survival (EFS)

Detailed description

Time to castration resistance, Radiographic progression-free survival (rPFS), PSA progression-free survival, Overall survival, Time to subsequent treatment, Symptomatic skeletal event free survival, Deep and/or ultradeep PSA response rate at 6 months, Time to initiate opioid use (≥ 7 days), Adverse events, serious adverse events, adverse events leading to treatment discontinuation and death., Change from baseline over time in each of the subscales of FACT-P, BPI-SF interference subscale and BFI .

Interventions

DRUGErleada 240 mg film-coated tablets
DRUGErleada 60 mg film-coated tablets
DRUGDocetaxel AqVida 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Sponsors

Alianza Multidisciplinar Para La Investigacion De Los Tumores Genitourinarios Guard
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Event-free Survival (EFS)—

Secondary

MeasureTime frame
Time to castration resistance, Radiographic progression-free survival (rPFS), PSA progression-free survival, Overall survival, Time to subsequent treatment, Symptomatic skeletal event free survival, Deep and/or ultradeep PSA response rate at 6 months, Time to initiate opioid use (≥ 7 days), Adverse events, serious adverse events, adverse events leading to treatment discontinuation and death., Change from baseline over time in each of the subscales of FACT-P, BPI-SF interference subscale and BFI .—

Outcome results

None listed

Source: EU CTIS · Data processed: May 21, 2026