Prostate cancer with biochemical recurrence after radical treatment MedDRA version: 20.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Fluciclovine (18F) injection
Pharmaceutical Form: Solution for injection
Sponsors
Blue Earth Diagnostics Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) The subject is a male =18 years old. (2) The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of: a. Post RRT / brachytherapy: Increase in PSA level =2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) [53], or b. Post RP: EITHER two consecutive rises in PSA and final PSA >0.1ng/ml OR three consecutive rises in PSA., This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels). i. In addition, the subject post RP, should have a PSA doubling time of =15 months OR PSA level =1.0 ng/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer Center nomogram (http://www.mskcc.org/nomograms/prostate/psa-doubling-time), based on a minimum of two PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening. (3) The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR. (4) The subject is being considered for radical salvage therapy. (5) The subject is able and willing to comply with study procedures, and signed, dated and timed informed consent is obtained before any study-related procedure is performed. (6) The subject’s Eastern Cooperative Oncology Group [ECOG] performance status 0-2. (7) The subject should not have received androgen-deprivation therapy within 3 months of screening. (8) The subject has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of study drug). 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 135
Exclusion criteria
Exclusion criteria: (1) The subject has been previously included in this study. (2) The subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before to 1 week after administration of fluciclovine (18F) injection. (3) The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents. (4) The subject has had a choline PET/CT scan within 3 months of the screening visit. (5) The subject has bilateral hip prostheses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical impact of fluciclovine (18F) PET/CT in affecting management decisions in patients with biochemical recurrence of prostate cancer (BCR) being considered for radical salvage treatment (with curative intent).; Secondary Objective: 1. To assess possible improvement in outcome of radical salvage treatment based on fluciclovine (18F) PET/CT being included in the assessment. 2. To assess the prostate specific antigen (PSA) threshold for positive lesion detection by fluciclovine (18F) PET/CT in BCR. 3. To assess the safety of fluciclovine (18F) injection in patients undergoing PET/CT. ;Primary end point(s): The primary endpoint of clinical impact of fluciclovine (18F) in affecting treatment decisions will be assessed by record of the revised treatment plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended treatment plan. ;Timepoint(s) of evaluation of this end point: After single dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess possible improvement in outcome of radical salvage treatment based on fluciclovine (18F) PET/CT being included in the assessment. This will be assessed as the proportion of these patients who have a treatment response or treatment failure within the follow-up period, using the following definitions: 1. Treatment response a. =50% decline in PSA [5] ± b. Radiological response 2. Treatment failure a. Increase or <50% decline in PSA ± b. Radiological progression. 2. To assess the prostate specific antigen (PSA) threshold for positive lesion detection by fluciclovine (18F) PET/CT in biochemical recurrence of prostate cancer (BCR). The positive detection rate will be calculated for the overall cohort and across a range of PSA values, to determine the optimum PSA threshold for lesion detection. 3. To assess the safety of fluciclovine (18F) injection in patients undergoing PET/CT Safety will be assessed from data on the occurrence of adverse events (AEs) and changes in clinical laboratory tests, vital signs, injection site status, and physical examination findings from the time of administration of fluciclovine (18F) injection throughout the study period. ; Timepoint(s) of evaluation of this end point: 1. during the follow-up period. 2. after single dose 3. after single dose 4. end of study 5. after single dose | — |
Countries
United Kingdom
Contacts
Public ContactBlue Earth Diagnostics Limited
Blue Earth Diagnostics Limited
Outcome results
None listed