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

March 14, 2024 updated by: Binshen Chen, Zhujiang Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510200
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
          • yiming zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: apalutamide combined with 89Sr and ADT
Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
Drug: Apalutamide
240mg, po, qd
Drug: 89Sr
100~150MBq(based on weight), iv, q90d
Drug: Luteinizing Hormone-Releasing Hormone Analog
sc, 3.6mg, q30d or 10.8mg, q90d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Up to 2 years after radical prostatectomy
progression-free survival
Up to 2 years after radical prostatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR
Time Frame: Up to 1 year
pathological complete response
Up to 1 year
rPFS
Time Frame: Up to 3 years
radiographic progression-free survival
Up to 3 years
PSA response rate
Time Frame: Up to 3 years
more than 50% decrease from baseline
Up to 3 years
pain score
Time Frame: 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.
Measured at baseline and follow up visits throughout the study, an average of 3 years
number and extent of bone metastases
Time Frame: Up to 3 years
Bone Scan
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Study Chair: Chen Binshen, Southern Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-KY-241-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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