One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515194-10-00

Acronym

SHR-3680-III-HSPC

Enrollment

Registered

2024-11-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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 with high tumor load

Brief summary

rPFS,OS

Detailed description

Time to PSA progression., Time to the next bone related event (including fracture, spinal compression, radiotherapy or surgery for bones)., Time to the start of the next anti-prostate cancer treatment., ORR, Safety endpoint.

Interventions

DRUGCasodex 50 mg Film-coated Tablets

DRUGZoladex 10

DRUG8 mg implantat

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
rPFS,OS	—

Secondary

Measure	Time frame
Time to PSA progression., Time to the next bone related event (including fracture, spinal compression, radiotherapy or surgery for bones)., Time to the start of the next anti-prostate cancer treatment., ORR, Safety endpoint.	—

Countries

Bulgaria, Czechia, Poland

Outcome results

None listed

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