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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04085991
• Other study ID #: CROSSBOW
• Status: Terminated
• Phase: Phase 2
• Start date: July 31, 2020
• Est. completion date: January 15, 2023

Study information

• Verified date: April 2023
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Prostate Cancer
• Metastatic Prostate Carcinoma in the Soft Tissue
• Metastatic Prostatic Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Stephan Probst	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months post last dose of RLT
Secondary	Adverse events	Frequency of adverse events in participants receiving therapy as per CTCAE v5.0	3 months post last dose of RLT