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

Not Applicable

Recruiting

• Conditions: High-Risk and Oligometastatic Prostate Cancer
• Interventions: Drug: Apalutamide

• Registration Number: NCT04997252
• Lead Sponsor: Zhujiang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
high-risk and oligometastatic prostate cance	Apalutamide	Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues

Primary Outcome Measures

Name	Time	Method
rPFS	Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.	radiographic progression-free survival

Secondary Outcome Measures

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

Trial Locations

Locations (1)

zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China