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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Treatments: Hormones; Prolactin Release-Inhibiting Factors

Criteria

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

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