Status:
TERMINATED
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
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, fail...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04085991
Start Date
July 31 2020
End Date
January 15 2023
Last Update
April 12 2023
Active Locations (1)
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1
Stephan Probst
Montreal, Quebec, Canada, H3T1E2