Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases

Not Applicable

Recruiting

• Conditions: Prostate Cancer With ≤10 Bone Metastases
• Interventions: Drug: Apalutamide; Drug: 89Sr; Drug: Luteinizing Hormone-Releasing Hormone Analog

• Registration Number: NCT05740488
• Lead Sponsor: Zhujiang Hospital

Brief Summary

The aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-07
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-02-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Prostate cancer confirmed by pathological findings;
2. Bone metastasis confirmed by bone scan, the number of bone metastases ≤10
3. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy;
4. ECOG score of 0 - 1
5. Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide therapy;
6. Voluntary signing of an ICF for the clinical trial

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apalutamide combined with 89Sr and ADT	89Sr	Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
apalutamide combined with 89Sr and ADT	Luteinizing Hormone-Releasing Hormone Analog	Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
apalutamide combined with 89Sr and ADT	Apalutamide	Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT

Primary Outcome Measures

Name	Time	Method
PFS	Up to 2 years after radical prostatectomy	progression-free survival

Secondary Outcome Measures

Name	Time	Method
PSA response rate	Up to 3 years	more than 50% decrease from baseline
rPFS	Up to 3 years	radiographic progression-free survival
pCR	Up to 1 year	pathological complete response
pain score	Measured at baseline and follow up visits throughout the study, an average of 3 years	Measurement of pain assessed by a Visual Analogue Scale (VAS). The analogous visual scale used for this study measures from 0 to 10 the intensity of pain with a series of "faces" that show the intensity in the pain experimentation with categories such as "No pain" in number 0, mild in number 1-3, moderate in number 4-6, intense in number 7-9 and worst in number 10.
number and extent of bone metastases	Up to 3 years	Bone Scan

Trial Locations

Locations (1)

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