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
Interventions
Product Name: rhPSMA-7.3 (18F)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
CAS Number: 2305081-62-1
Current Sponsor code: rhPSMA-7.3 (18F)
Other descriptive name: Ga
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. Patient with a history of localized adenocarcinoma of the prostate with prior curative intent treatment, experiencing BCR of PCa potentially eligible for salvage therapy with curative intent, following prior treatment with one or more of the following: a) RP, b) RP plus adjuvant RT, c) RP plus adjuvant androgen deprivation therapy (ADT), d) external beam radiation therapy or e) focal gland therapies (e.g. brachytherapy, high-intensity focused ultrasound [HIFU]) - At least 6 weeks must have elapsed after RP. - If previously taking ADT, it should have been discontinued at least 16 weeks prior to screening. - In the case of focal gland therapies (e.g. HIFU) and RT, the treatment will have occurred at least 1 year prior to screening. 4. An elevated PSA, clinically suspicious for biochemically recurrent disease, that meets one of the following conditions: - Following RP with or without adjuvant or salvage therapy: initial PSA =0.2 ng/mL followed by a subsequent confirmatory PSA value =0.2 ng/mL. - Following RT (e.g. radical radiotherapy or brachytherapy) as the primary treatment: nadir +2 ng/mL. - Following focal gland therapies (e.g. HIFU) as the primary treatment: nadir +2 ng/mL. 5. Patient willing to undergo biopsy for histological confirmation of rhPSMA-7.3 (18F) PET findings, where safe and feasible. 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 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 126
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 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 patient level Correct Detection Rate (CDR) and region level positive predictive value (PPV) of rhPSMA-7.3 (18F) PET for biochemical recurrence of PCa using histopathology or imaging as a Standard of Truth. The CDR is defined as the percentage of all patients scanned who have at least one true positive (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 rhPSMA-7.3 (18F) PET-positive regions will be categorized as TP or FP regions using histopathology or imaging. ;Secondary Objective: To assess: - the patient level CDR and region level PPV of rhPSMA-7.3 (18F) PET in the subgroup of patients who have negative baseline conventional imaging - the patient level CDR and region level PPV of rhPSMA-7.3 (18F) PET separated into subgroups of patients with reference standard histopathology available and unavailable - the patient level CDR and region level PPV of rhPSMA-7.3 (18F) PET stratified by PSA level - the CDR of rhPSMA-7.3 (18F) PET on a region level - the impact of rhPSMA-7.3 (18F) results on the intended clinical management of study participants using a clinician survey - the inter- and intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by the blinded independent readers - the safety of rhPSMA-7.3 (18F) injection in patients ;Primary end point(s): - patient level CDR defined as the percentage of all patients scanned who have at least one TP lesion (localized correspondence between rhPSMA-7.3 (18F) PET imaging and the reference standard) regardless of any coexisting FP findings - region level PPV (defined as TP/{TP+FP}) of rhPSMA-7.3 (18F) PET;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Patient level CDR and region level PPV of rhPSMA-7.3 (18F) PET in the subgroup of patients who have negative baseline conventional imaging 2. 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 3. Patient level CDR and region level PPV of rhPSMA-7.3 (18F) PET stratified by PSA level 4. CDR of rhPSMA-7.3 (18F) PET in the following regions: local recurrence, pelvic lymph nodes, other 5. Percentage of patients in whom rhPSMA-7.3 (18F) PET imaging results changed the intended patient management (major and other changes) 6. Reader kappa statistics of rhPSMA-7.3 (18F) scan interpretation by the blinded independent readers 7. Safety (AEs and vital signs) of rhPSMA 7.3 (18F) injection in patients ;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Countries
Finland, Germany, Netherlands, United States
Contacts
Public ContactJames O'Neill
Blue Earth Diagnostics, Inc
Outcome results
None listed