Brief Summary
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.
Brief Title
Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
Detailed Description
Main objective is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central blinded image evaluation \[BIE\]) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during radical prostatectomy (RP) and pelvic lymph node dissection (PLND). At least one positive pelvic LN on PET (N1) and one positive lymph node (LN) as determined by histopathology (pN1) on the same side of the pelvis (left or right) will be deemed a True Positive (TP) at the patient level.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
1. Patient is male and aged \>18 years old.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
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, or with a prior history of, Androgen Deprivation Therapy (ADT).
1. Patient is male and aged \>18 years old.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
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, or with a prior history of, Androgen Deprivation Therapy (ADT).
Inclusion Criteria
Inclusion Criteria:
1. Patient is male and aged \>18 years old.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
1. Patient is male and aged \>18 years old.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
Gender
Male
Gender Based
false
Keywords
Primary 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
NCT04186819
Org Class
Industry
Org Full Name
Blue Earth Diagnostics
Org Study Id
BED-PSMA-301
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) Positron Emission Tomography (PET) Ligand in Men With Newly Diagnosed Prostate Cancer
Primary Outcomes
Outcome Description
The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Outcome Measure
Specificity
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Outcome Description
The primary objective of the study is to assess the sensitivity and specificity of rhPSMA-7.3 (18F) positron emission tomography (PET) in detecting N1 disease (as determined by the central BIE) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Outcome Measure
Sensitivity
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Secondary Outcomes
Outcome Description
This was a key secondary endpoint in this study and included patients in the EEP with rhPSMA-7.3 (18F) imaging.
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET. followed by treatment within 60 days post IMP administration
Outcome Measure
Verified Detection Rate (VDR) for M1 Lesions - Percentage of Patients in Whom rhPSMA-7.3 (18F) Imaging Detected at Least One Verified M1 Metastasis, as Determined by Central BIE and Confirmed by SoT (Biopsy or Imaging) (Objective 1)
Outcome Description
Patients counted in this variable were a subset of those in Point 1 above, where both the numerator and denominator were only counting patients with negative conventional imaging (according to investigator assessment) for M1 disease.
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Outcome Measure
Percentage of Patients With Negative Conventional Imaging for M1 Disease in Whom rhPSMA-7.3 (18F) PET Detected at Least One Verified M1 Metastasis, as Determined by Central BIE (Objective 2)
Outcome Description
This analysis included patients with rhPSMA-7.3 (18F) imaging and either N1 or M1 lesions detected, where PPV=TP/(TP+FP).
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Outcome Measure
Patient-level PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 Lesions Compared to Histopathology or Confirmatory Imaging (M1 Lesions Only) (Objective 3)
Outcome Description
This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology.
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Outcome Measure
PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)
Outcome Description
This analysis included patients in the EAP with rhPSMA-7.3 (18F) imaging where no LN metastases were detected and LN surgical pathology was available; where NPV=TN/(TN+FN).
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Outcome Measure
NPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FN Patient is Defined as Having at Least One FN Region (Right or Left Pelvis), Regardless of Any Coexisting TN Findings (Objective 5)
Outcome Description
TP \[confirmed by SoT\] central BIE PET finding and negative conventional imaging finding from the local reading
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Outcome Measure
The Percentage of Patients Being Upstaged to N1 or M1 Disease. (Objective 6a)
Outcome Time Frame
Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration
Outcome Measure
The Percentage of Patients in Whom Planned RP Was Converted to EBRT. (Objective 6b)
Outcome Description
Pairwise agreement between any 2 of the 3 readers (Kappa statistic could not be calculated for 2 of the pairwise agreements), and within readers between the initial read and re-read (Kappa statistics could not be calculated for 2 of the within-reader agreements)
Outcome Time Frame
PET/CT scans on Day 1
Outcome Measure
Kappa Statistic for the Agreement Between and Within Blinded Independent Readers on the Interpretation of rhPSMA-7.3 (18F) Scans (Objective 7)
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