Prostate cancer MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Blue Earth Diagnostics Ireland Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible. 2. Patient is male and aged >18 years old. 3. Histologically confirmed adenocarcinoma of the prostate. 4. Candidate for RP with PLND and scheduled to undergo the surgical procedure. 5. Patient with either: a) Unfavorable intermediate risk (disease, defined as: - Any Gleason Grade Grouping [GGG] 3, or - GGG 2 with =50% of biopsy cores positive for PCa and/or >1 Intermediate Risk Factor [T2b; T2c; PSA 10-20] or b) High risk or very high risk disease (per NCCN Guidelines Version 1.2020; PROS 2). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 225 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements. 2. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan. 3. Patients currently receiving, or with a prior history of, androgen deprivation therapy (ADT; defined as surgical orchidectomy; luteinizing hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent]; LHRH antagonist alone [continuous or intermittent]; administration or use of a first generation or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist). 4. Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to administration of rhPSMA-7.3 (18F). 5. Patients with known hypersensitivity to the active substance or to any of the excipients of the IP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the sensitivity and specificity of rhPSMA-7.3 (18F) 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. At least one positive pelvic LN on PET (N1) and one positive 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. ;Secondary Objective: To assess: Verified Detection Rate(VDR) for M1 disease of IMP PET on patient(pt) level in pts with 1)newly diagnosed unfavorable intermediate-, high-, or very high-risk PCa using histopathology(HP) or confirmatory imaging(CI) or 2)negative CI. Positive predictive value(PPV) of IMP PET for N1 and M1 lesions compared(cf) to HP or CI PPV of IMP PET to detect pelvic LN mets cf to surgical pathology on a pt level in which a False Positive(FP) pt is defined as =1 FP region (R or L pelvis), regardless of coexisting TP findings. Negative predictive value(NPV) of IMP PET to detect pelvic LN mets cf to surgical pathology on a pt level in which a False Negative(FN) pt is defined as having =1 FN region(R or L pelvis), regardless of any coexisting True Negative(TN) findings. Impact of IMP on a)upstaging pts planned for RP or b)converting planned RP to external beam radiation therapy(EBRT). Inter- and intra-reader agreement of IMP scan interpretation by blinded independent readers. Safety of IMP.;Primary end point(s): • Sensitivity of rhPSMA-7.3 (18F) PET (as determined by central BIE) for detecting pelvic LN metastases compared to surgical pathology on a patient level. • Specificity of rhPSMA-7.3 (18F) PET (as determined by central BIE) for detecting pelvic LN metastases compared to surgical pathology on a patient level. ;Timepoint(s) of evaluation of this end point: After a single dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of patients in whom rhPSMA-7.3 (18F) imaging detects at least one verified M1 metastasis, as determined by central BIE. 2. Percentage of patients with negative conventional imaging for M1 disease in whom rhPSMA-7.3 (18F) PET detects at least one verified M1 metastasis, as determined by central BIE. 3. PPV of rhPSMA-7.3 (18F) PET BIE for N1 and M1 lesions compared to histopathology or confirmatory imaging (M1 lesions only). 4. PPV of rhPSMA-7.3 (18F) PET for detecting pelvic LN 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. 5. NPV of rhPSMA-7.3 (18F) PET for detecting pelvic LN 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. 6. a) The percentage of patients being upstaged to N1 or M1 disease; b) The percentage of patients in whom planned RP is converted to EBRT. 7. Kappa statistic for the agreement between and within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans. 8. Safety (AEs, vital signs clinical laboratory evaluations, 12-lead ECG and focused physical examinations) of rhPSMA-7.3 (18F) injection in patients. ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Finland, Germany, Netherlands, United States
Contacts
Public ContactJames O'Neill
Blue Earth Diagnostics, Inc
Outcome results
None listed