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

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
131I-PSMA-1095 Radioligand Therapy (RLT)
Sponsored by
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Radioligand therapy, PSMA, PSMA therapy, 1095

Eligibility Criteria

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

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)

Sites / Locations

  • Stephan Probst

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

131I-PSMA-1095 Radioligand Therapy (RLT)

Arm Description

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

Outcomes

Primary Outcome Measures

Serum prostate specific antigen (PSA)
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

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

Full Information

First Posted
September 8, 2019
Last Updated
April 10, 2023
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04085991
Brief Title
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
Acronym
CROSSBOW
Official Title
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Drug no longer available
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Prostatic Neoplasms, Metastatic Prostate Cancer, Metastatic Prostatic Adenocarcinoma, Metastatic Prostate Carcinoma in the Soft Tissue
Keywords
Radioligand therapy, PSMA, PSMA therapy, 1095

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
131I-PSMA-1095 Radioligand Therapy (RLT)
Arm Type
Experimental
Arm Description
Intravenous injection of 100 mCi of 131I-PSMA-1095 RLT, Q8 weeks up to a maximum of 4 doses
Intervention Type
Drug
Intervention Name(s)
131I-PSMA-1095 Radioligand Therapy (RLT)
Other Intervention Name(s)
PSMA RLT
Intervention Description
Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.
Primary Outcome Measure Information:
Title
Serum prostate specific antigen (PSA)
Description
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.
Time Frame
3 months post last dose of RLT
Secondary Outcome Measure Information:
Title
Adverse events
Description
Frequency of adverse events in participants receiving therapy as per CTCAE v5.0
Time Frame
3 months post last dose of RLT

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male only.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Probst, MD
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephan Probst
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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