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Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
225Ac-PSMA
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring mCRPC, PSMA radioligand therapy, efficacy, safety

Eligibility Criteria

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

Inclusion Criteria:

  • Pathologically confirmed prostatic adenocarcinoma.
  • Clinically or imaging confirmed metastatic castration resistant prostate cancer.
  • Conventional treatment failure or not available.
  • PSMA avid of lesions confirmed by PSMA PET/CT.
  • Hematopoietic function, kidney and liver function is normal.
  • Can follow the study plan and can timely follow-up.
  • Agree to sign the informed consent.

Exclusion Criteria:

  • Pathological types other than the prostatic adenocarcinoma of prostate cancer.
  • Not PSMA avid of lesions confirmed by PSMA PET/CT.
  • Concurrent with other uncontrolled malignant tumours or five years, except for carcinoma in situ.
  • Concomitant diseases are not suitable for radioactive therapy.
  • Other conditions (religion, psychology, etc.) affect the informed consent, research plan, or not compliant of follow-up schedule.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    mCRPC for PSMA RLT

    Arm Description

    225Ac-PSMA 100KBq/kg, iv. Totally 2 doses, every 8 weeks.

    Outcomes

    Primary Outcome Measures

    serum PSA level
    Serum prostate specific antigen (PSA) levels was used as the main marker of efficacy evaluation, and the changes of PSA level were divided into decrease > 50%, 30% ~ 50% and < 30%.

    Secondary Outcome Measures

    Adverse Events and Serious Adverse Events
    Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Full Information

    First Posted
    October 7, 2019
    Last Updated
    January 8, 2020
    Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04225910
    Brief Title
    Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer
    Official Title
    Prospective Pilot Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2021 (Anticipated)
    Study Completion Date
    December 21, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    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 death of prostate cancer patients is mainly due to metastatic castration-resistant prostate cancer. Though some new therapies has been tried to prolong the life-span of mCRPC patients, a dilemma was encountered for the drug-resistance. The PSMA RLT has been tested its efficacy and safety for the therapy of these patients. In our clinical trial, a new PSMA ligand will been used to be labeled with Ac225. This will be a prospective pilot clinical trial. 20 mCRPC patients who was incapable of 2rd ADT or chemotherapy will be recruited in this clinical tiral. The efficacy and safety of 225Ac-PSMA will be evaluated after the administration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Castration-resistant Prostate Cancer
    Keywords
    mCRPC, PSMA radioligand therapy, efficacy, safety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mCRPC for PSMA RLT
    Arm Type
    Experimental
    Arm Description
    225Ac-PSMA 100KBq/kg, iv. Totally 2 doses, every 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    225Ac-PSMA
    Intervention Description
    all the patients will receive 225Ac-PSMA RLT for 2 cycles. The dosage will be calculated according to 100KBq/kg body weight. The drug will be administered by vein injection.
    Primary Outcome Measure Information:
    Title
    serum PSA level
    Description
    Serum prostate specific antigen (PSA) levels was used as the main marker of efficacy evaluation, and the changes of PSA level were divided into decrease > 50%, 30% ~ 50% and < 30%.
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Adverse Events and Serious Adverse Events
    Description
    Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
    Time Frame
    through study completion, an average of 1 year.

    10. Eligibility

    Sex
    Male
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pathologically confirmed prostatic adenocarcinoma. Clinically or imaging confirmed metastatic castration resistant prostate cancer. Conventional treatment failure or not available. PSMA avid of lesions confirmed by PSMA PET/CT. Hematopoietic function, kidney and liver function is normal. Can follow the study plan and can timely follow-up. Agree to sign the informed consent. Exclusion Criteria: Pathological types other than the prostatic adenocarcinoma of prostate cancer. Not PSMA avid of lesions confirmed by PSMA PET/CT. Concurrent with other uncontrolled malignant tumours or five years, except for carcinoma in situ. Concomitant diseases are not suitable for radioactive therapy. Other conditions (religion, psychology, etc.) affect the informed consent, research plan, or not compliant of follow-up schedule.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hui Wang, Professor
    Phone
    86-021-25076980
    Email
    wanghuishanghai@hotmaill.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hongliang Fu
    Phone
    86-021-25078591
    Email
    fuhongliang@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer

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