An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer

Sponsor
Zhujiang Hospital
Study ID
NCT04997252
Status
Unknown

Conditions

  • High-Risk and Oligometastatic Prostate Cancer

Eligibility Criteria

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

Interventions

Study Details

The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.

Key Dates

Start date
Feb 1, 2021
Status verified
Mar 2024
Primary completion
Aug 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: high-risk and oligometastatic prostate cance
    Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues

Primary Outcome Measure

rPFS [ Time Frame: Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months. ]

Central Contacts