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

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.

Study Overview

• Status: Recruiting
• Conditions: High-Risk and Oligometastatic Prostate Cancer
• Intervention / Treatment: Drug: Apalutamide

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhang yiming; Phone Number: 020-62782726; Email: 59281481@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510200
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: yiming zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-risk and oligometastatic prostate cance; Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues	Drug: Apalutamide; apalutamide as neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR	pathological complete response	preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
PFS	positive margin rate; progression-free survival	preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
PSA response rate:	more than 50% decrease from baseline	preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
TTPP	time to PSA progression	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.
pathological stage		preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Chen-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No