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A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502686-24-00
Acronym
56021927PCR3020
Enrollment
78
Registered
2023-09-25
Start date
2023-11-22
Completion date
Unknown
Last updated
2025-09-10

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

Conditions

Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Brief summary

- 18-month radiographic progression-free survival rate. Radiographic progression will be assessed by investigators using conventional imaging - 18-month percent change in severity adjusted hot flash score

Interventions

DRUG-

Sponsors

Janssen - Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
- 18-month radiographic progression-free survival rate. Radiographic progression will be assessed by investigators using conventional imaging - 18-month percent change in severity adjusted hot flash score

Countries

France, Germany, Poland

Outcome results

None listed

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