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

NCT ID: NCT04997252

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

High-Risk and Oligometastatic Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high-risk and oligometastatic prostate cance

Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues

Group Type: EXPERIMENTAL

Apalutamide

Intervention Type: DRUG

apalutamide as neoadjuvant therapy

Interventions

Apalutamide

apalutamide as neoadjuvant therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adult males aged above 18 years old, no healthy volunteers included;

2. Prostate cancer confirmed by pathological findings;

3. High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;

4. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;

5. ECOG score of 0 - 1

6. Agreement to undergo preoperative and postoperative endocrine therapy;

7. Voluntary signing of an ICF for the clinical trial

Exclusion Criteria

1. Any other tumor disease requiring treatment;

2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;

3. A history of epilepsy or any condition that may lead to seizures;

4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Binshen Chen

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang yiming

Role: CONTACT

59281481@qq.com

020-62782726

Facility Contacts

yiming zhang

Role: primary

Other Identifiers

Chen-001

Identifier Type: -

Identifier Source: org_study_id