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

NCT04997252 | Recruiting

• 1 other identifier: Chen-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• rPFS

  radiographic progression-free survival

  Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.

Secondary Outcomes (6)

• pCR

  preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.

• PFS

  preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.

• PSA response rate:

  preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.

• TTPP

  preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.

• time to BCR after surgery

  preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.

Study Arms (1)

high-risk and oligometastatic prostate cance

EXPERIMENTAL

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

Drug: Apalutamide

Interventions

Apalutamide DRUG

apalutamide as neoadjuvant therapy

high-risk and oligometastatic prostate cance

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males aged above 18 years old, no healthy volunteers included;
• Prostate cancer confirmed by pathological findings;
• High risk based on risk assessment, or laboratory tests suggestive of oligometastasis;
• Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
• ECOG score of 0 - 1
• Agreement to undergo preoperative and postoperative endocrine therapy;
• Voluntary signing of an ICF for the clinical trial

You may not qualify if:

• Any other tumor disease requiring treatment;
• Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
• A history of epilepsy or any condition that may lead to seizures;
• Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510200, China

RECRUITING

MeSH Terms

Interventions

apalutamide

Central Study Contacts

Zhang yiming

CONTACT

020-62782726; 59281481@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 9, 2021
• Study Start: February 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CN (1)