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

NCT05740488 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-15

No results posted yet for this study

Summary

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.

Conditions

  • Prostate Cancer With ≤10 Bone Metastases

Interventions

DRUG

Apalutamide

240mg, po, qd

DRUG

89Sr

100\~150MBq(based on weight), iv, q90d

DRUG

Luteinizing Hormone-Releasing Hormone Analog

sc, 3.6mg, q30d or 10.8mg, q90d

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Chen Binshen · Southern Medical University, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2025-04-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740488 on ClinicalTrials.gov