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

Last updated: March 14, 2024
Sponsor: Zhujiang Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Urologic Cancer

Prostate Cancer

Treatment

Apalutamide

Luteinizing Hormone-Releasing Hormone Analog

89Sr

Clinical Study ID

NCT05740488
2022-KY-241-02
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 89Srradionuclide therapy;
  6. Voluntary signing of an ICF for the clinical trial

Exclusion

Exclusion Criteria:

  1. Any other tumor disease requiring treatment;
  2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or thepossibility 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

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Apalutamide
Phase:
Study Start date:
January 07, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510200
    China

    Active - Recruiting

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