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

Primary Purpose

Prostate Cancer With ≤10 Bone Metastases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Apalutamide
89Sr
Luteinizing Hormone-Releasing Hormone Analog
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer With ≤10 Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    apalutamide combined with 89Sr and ADT

    Arm Description

    Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT

    Outcomes

    Primary Outcome Measures

    PFS
    progression-free survival

    Secondary Outcome Measures

    pCR
    pathological complete response
    rPFS
    radiographic progression-free survival
    PSA response rate
    more than 50% decrease from baseline
    pain score
    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
    Bone Scan

    Full Information

    First Posted
    February 8, 2023
    Last Updated
    February 22, 2023
    Sponsor
    Zhujiang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05740488
    Brief Title
    Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
    Official Title
    Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2023 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhujiang Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer With ≤10 Bone Metastases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    apalutamide combined with 89Sr and ADT
    Arm Type
    Experimental
    Arm Description
    Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
    Intervention Type
    Drug
    Intervention Name(s)
    Apalutamide
    Intervention Description
    240mg, po, qd
    Intervention Type
    Drug
    Intervention Name(s)
    89Sr
    Intervention Description
    100~150MBq(based on weight), iv, q90d
    Intervention Type
    Drug
    Intervention Name(s)
    Luteinizing Hormone-Releasing Hormone Analog
    Intervention Description
    sc, 3.6mg, q30d or 10.8mg, q90d
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    progression-free survival
    Time Frame
    Up to 2 years after radical prostatectomy
    Secondary Outcome Measure Information:
    Title
    pCR
    Description
    pathological complete response
    Time Frame
    Up to 1 year
    Title
    rPFS
    Description
    radiographic progression-free survival
    Time Frame
    Up to 3 years
    Title
    PSA response rate
    Description
    more than 50% decrease from baseline
    Time Frame
    Up to 3 years
    Title
    pain score
    Description
    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.
    Time Frame
    Measured at baseline and follow up visits throughout the study, an average of 3 years
    Title
    number and extent of bone metastases
    Description
    Bone Scan
    Time Frame
    Up to 3 years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhang Yiming
    Phone
    020-62782726
    Email
    359281481@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chen Binshen
    Organizational Affiliation
    Southern Medical University, China
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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