Trials / Terminated
TerminatedNCT04085991
Two TraCer PositROn EmiSSion Tomography ComBination for Efficacy EstimatiOn of Prostate Specific Membrane Antigen Radioligand Therapy in Patients With Metastatic Prostate Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Prostate Cancer
- Prostate Adenocarcinoma
- Prostatic Neoplasms
- Metastatic Prostate Cancer
- Metastatic Prostatic Adenocarcinoma
- Metastatic Prostate Carcinoma in the Soft Tissue
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-31
- Primary completion
- 2023-01-15
- Completion
- 2023-01-15
- First posted
- 2019-09-11
- Last updated
- 2023-04-12
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04085991. Inclusion in this directory is not an endorsement.