Brief Summary
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.
Brief Title
Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence
Detailed Description
The primary objective of this study was to assess the patient-level correct detection rate (CDR) and region-level positive predictive value (PPV) of rhPSMA-7.3 (18F) positron emission tomography (PET) for biochemical recurrence (BCR) of prostate cancer using histopathology or imaging as a standard of truth (SoT).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
1. Patient is male and aged \>18 years old.
2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.
3. An elevated PSA, clinically suspicious for biochemically recurrent disease:
* Following Radical Prostatectomy: PSA \>0.2 ng/mL
* Following Radiotherapy: nadir +2 ng/mL.
4. Potentially eligible for salvage therapy with curative intent.
Exclusion Criteria:
1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
2. Patients currently receiving Androgen Deprivation Therapy (ADT).
1. Patient is male and aged \>18 years old.
2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.
3. An elevated PSA, clinically suspicious for biochemically recurrent disease:
* Following Radical Prostatectomy: PSA \>0.2 ng/mL
* Following Radiotherapy: nadir +2 ng/mL.
4. Potentially eligible for salvage therapy with curative intent.
Exclusion Criteria:
1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
2. Patients currently receiving Androgen Deprivation Therapy (ADT).
Inclusion Criteria
Inclusion Criteria:
1. Patient is male and aged \>18 years old.
2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.
3. An elevated PSA, clinically suspicious for biochemically recurrent disease:
* Following Radical Prostatectomy: PSA \>0.2 ng/mL
* Following Radiotherapy: nadir +2 ng/mL.
4. Potentially eligible for salvage therapy with curative intent.
1. Patient is male and aged \>18 years old.
2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.
3. An elevated PSA, clinically suspicious for biochemically recurrent disease:
* Following Radical Prostatectomy: PSA \>0.2 ng/mL
* Following Radiotherapy: nadir +2 ng/mL.
4. Potentially eligible for salvage therapy with curative intent.
Gender
Male
Gender Based
false
Keywords
Recurrent Prostate Cancer
Diagnostic
Prostate Specific Membrane Antigen (PSMA)
Positron Emission Tomography (PET) Scan
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04186845
Org Class
Industry
Org Full Name
Blue Earth Diagnostics
Org Study Id
BED-PSMA-302
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy (SPOTLIGHT)
Primary Outcomes
Outcome Description
The CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings. When determining the region-level PPV, all rhPSMA7.3 (18F) PET-positive regions (maximum of three per patient) were categorized as TP or FP regions using histopathology or imaging.
Outcome Measure
Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT
Outcome Time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Secondary Outcomes
Outcome Description
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings.
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Outcome Time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Outcome Measure
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging
Outcome Description
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings.
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.
Outcome Time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Outcome Measure
Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Outcome Description
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The last PSA level before the PET scan will be used to stratify the patients
Outcome Time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Outcome Measure
Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Outcome Description
Patient-level CDR was defined as the percentage of all patients scanned who had at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any co-existing FP findings. The analysis was performed for each region and for each of the blinded independent readers
Outcome Time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Outcome Measure
CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other
Outcome Description
This analysis used patients in the EAP who had documented patient management plans in the EDC before and after the rhPSMA-7.3 (18F) PET scan
Outcome Time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Outcome Measure
Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes)
Outcome Description
The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers
Outcome Time Frame
PET Scan on Day 1
Outcome Measure
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
Outcome Description
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions.. The last PSA level before the rhPSMA-7.3 (18F) PET scan was used to stratify patients.
Outcome Time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Outcome Measure
Region-level PPV of rhPSMA-7.3 (18F) PET Stratified by PSA Level
Outcome Description
Region-Level PPV is defined as the regions which are true positive out of all regions with positive lesions. The data are analysed by whether the patients have had histopathology as reference standard.
Outcome Time Frame
Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan
Outcome Measure
Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Gartrell
Investigator Email
bgartrel@montefiore.org
Investigator Phone
718-405-8404