Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases

Sponsor
Zhujiang Hospital
Study ID
NCT05740488
Status
Unknown

Conditions

  • Prostate Cancer With ≤10 Bone Metastases

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    240mg, po, qd
  • 89Sr — DRUG
    100\~150MBq(based on weight), iv, q90d
  • Luteinizing Hormone-Releasing Hormone Analog — DRUG
    sc, 3.6mg, q30d or 10.8mg, q90d

Study Details

The aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.

Key Dates

Start date
Jan 7, 2022
Status verified
Mar 2024
Primary completion
Apr 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: apalutamide combined with 89Sr and ADT
    Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT

Primary Outcome Measure

PFS [ Time Frame: Up to 2 years after radical prostatectomy ]

Central Contacts