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

NCT05740488 | Recruiting

• 1 other identifier: 2022-KY-241-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer With ≤10 Bone Metastases

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  Up to 2 years after radical prostatectomy

Secondary Outcomes (5)

• pCR

  Up to 1 year

• rPFS

  Up to 3 years

• PSA response rate

  Up to 3 years

• pain score

  Measured at baseline and follow up visits throughout the study, an average of 3 years

• number and extent of bone metastases

  Up to 3 years

Study Arms (1)

apalutamide combined with 89Sr and ADT

EXPERIMENTAL

Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT

Drug: Apalutamide; Drug: 89Sr; Drug: Luteinizing Hormone-Releasing Hormone Analog

Interventions

Apalutamide DRUG

240mg, po, qd

apalutamide combined with 89Sr and ADT

89Sr DRUG

100\~150MBq(based on weight), iv, q90d

apalutamide combined with 89Sr and ADT

Luteinizing Hormone-Releasing Hormone Analog DRUG

sc, 3.6mg, q30d or 10.8mg, q90d

apalutamide combined with 89Sr and ADT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any other tumor disease requiring treatment;
• Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis;
• A history of epilepsy or any condition that may lead to seizures;
• Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510200, China

RECRUITING

MeSH Terms

Interventions

apalutamide; Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Chen Binshen

  Southern Medical University, China

  STUDY CHAIR

Central Study Contacts

Zhang Yiming

CONTACT

020-62782726; 359281481@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 23, 2023
• Study Start: January 7, 2022
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)