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CROSSBOW: Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer

Sponsor
Sir Mortimer B. Davis - Jewish General Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04085991
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
52.5
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Single-arm, open-label, phase II trial in 200 competent adult male patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-3 and progressive metastatic prostate cancer, failing, failed, refused, not eligible for or no access to further approved lines of therapy. Patients will undergo sequential FDG positron emission tomography (PET) and 18F-DCFPyL PET to assess FDG/DCFPyL concordance fraction. Patients with DCFPyL/FDG concordance of 50% or greater will be treated with 131I-PSMA-1095 radioligand therapy (RLT). Best post-treatment serum prostate specific antigen response will be compared to concordance fraction.

Condition or Disease Intervention/Treatment Phase
  • Drug: 131I-PSMA-1095 Radioligand Therapy (RLT)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
Actual Study Start Date :
Jul 31, 2020
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Dec 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 131I-PSMA-1095 Radioligand Therapy (RLT)

Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses

Drug: 131I-PSMA-1095 Radioligand Therapy (RLT)
Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.
Other Names:
  • PSMA RLT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum prostate specific antigen (PSA) [3 months post last dose of RLT]

      The best serum prostate specific antigen (PSA) response will be calculated for each patient as: pre-treatment PSA minus lowest post-treatment PSA divided by pre-treatment PSA. Best PSA response will be reported as percent reduction (or increase) from baseline.

    Secondary Outcome Measures

    1. Adverse events [3 months post last dose of RLT]

      Frequency of adverse events in participants receiving therapy as per CTCAE v5.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male

    • Age 18 years or older

    • Documented metastatic adenocarcinoma of the prostate

    • Under active medical oncology care

    • ECOG performance status 0 - 3, inclusive

    • Able to understand and provide written informed consent

    • Able to tolerate the physical requirements of two PET/CT scans including lying for up to 30 minutes

    • Progressive disease on any of: bone scan, CT, MRI or serum PSA as judged by the investigator

    • Serum prostate specific antigen ≥ 1 ng/ml at baseline or CT/MRI soft-tissue measurable disease as per RECIST v1.1

    • Failed, failing, refused, no access to or not eligible for any approved prostate cancer therapies including but not limited to: ADT, NAAD (e.g., abiraterone, enzalutamide, darolutamide or apalutamide), docetaxel, cabazitaxel, radium-223 and oligometastatic RTX

    • Life expectancy of at least 3 months as judged by the investigator

    Exclusion Criteria:

    • Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)

    • Exceeding the weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (approximately 70 cm diameter)

    • Unmanageable claustrophobia

    • Prior failure of PSMA RLT

    • Prior hemi-body irradiation

    • Impaired organ function as evidenced by any of the following laboratory values:

    • Absolute neutrophil count < 1.5 x109/L

    • Platelet count < 75 x109/L

    • Hemoglobin < 85 g/L

    • Albumin < 2.5 g/dL (25 g/L)

    • Total bilirubin > 2 x ULN (unless in instances of Gilbert's disease)

    • AST or ALT > 2.5 x ULN (or > 5.0 x ULN in the presence of liver metastases)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stephan Probst Montreal Quebec Canada H3T1E2

    Sponsors and Collaborators

    • Sir Mortimer B. Davis - Jewish General Hospital

    Investigators

    • Principal Investigator: Stephan Probst, MD, Jewish General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephan Probst, MD, Chief of Nuclear Medicine, Sir Mortimer B. Davis - Jewish General Hospital
    ClinicalTrials.gov Identifier:
    NCT04085991
    Other Study ID Numbers:
    • CROSSBOW
    First Posted:
    Sep 11, 2019
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stephan Probst, MD, Chief of Nuclear Medicine, Sir Mortimer B. Davis - Jewish General Hospital
    Radioligand therapy
    PSMA
    PSMA therapy
    1095
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Adenocarcinoma

    Study Results

    No Results Posted as of Sep 27, 2021