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| Name | Class |
|---|---|
| Innovate UK | OTHER_GOV |
| Syne Qua Non Limited | INDUSTRY |
| IND 2 Results LLC | INDUSTRY |
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The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer) on the clinical and treatment decision required for managing patients with biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment with the intention of providing disease cure. Also, this study will consolidate the information regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively followed patients at several centres in the UK and assess the effect of PSA level on the likelihood of detecting cancer lesions by 18F-fluciclovine
Proposed Research In the setting of growing single-centre evidence of superior diagnostic performance of 18F-fluciclovine PET/CT in BCR, our primary aim is to assess its clinical impact on treatment decisions in a multi-centre study in patients with BCR being considered for radical salvage treatment (with curative intent). In addition, we aim to further characterise its diagnostic performance, afforded by larger numbers of patients from multi-centre recruitment. We also aim to assess the effect of PSA level on probability of lesion detection by 18F-fluciclovine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Single intravenous administration of 18F-Fluciclovine for PET Scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluciclovine PET CT | Drug | Radioligand for PET CT scanning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact on Patient Treatment /Management | The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate to Radical Salvage Therapy | To establish the proportion of patients who have a sustained response to radical salvage therapy. | 7 months |
| PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR |
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Inclusion Criteria:
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 biochemical recurrence (BCR) on the basis of:
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.
The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
The subject is being considered for radical salvage therapy.
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.
The subject's Eastern Cooperative Oncology Group [ECOG] performance status 0-2.
The subject should not have received androgen-deprivation therapy within 3 months of screening.
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).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fergus Gleeson, FRCP FRCR | The Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Vernon Cancer Centre, Mount Vernon Hospital | Northwood | Middlesex | HA6 2RN | United Kingdom | ||
| Churchill Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37121865 | Derived | Andriole GL, Scarsbrook AF, Savir-Baruch B; LOCATE/FALCON Study Groups. Impact of 18F-fluciclovine PET/CT on plans for androgen deprivation therapy in patients with biochemical recurrence of prostate cancer: data analysis from two prospective clinical trials. Urol Oncol. 2023 Jun;41(6):293.e1-293.e7. doi: 10.1016/j.urolonc.2023.04.004. Epub 2023 Apr 29. | |
| 32068113 |
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This study was conducted between 27 November 2015 (first patient, screening visit) and 22 June 2018 (last patient, completed) at seven sites (one did not enrol) in the UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Single intravenous administration of 18F-Fluciclovine for PET Scan 18F-Fluciclovine PET CT: Radioligand for PET CT scanning |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Single intravenous administration of 18F-Fluciclovine for PET Scan 18F-Fluciclovine PET CT: Radioligand for PET CT scanning |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Impact on Patient Treatment /Management | The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan. | For the primary analysis population, of the 104 patients included in the EAS, 58 patients with a positive 18F fluciclovine scan and 46 patients with a negative 18F fluciclovine scan had a pre-18F fluciclovine PET/CT management plan. | Posted | Count of Participants | Participants | 1 month |
|
|
As specified in the Statistical Analysis Plan, results are presented as only those treatment-emergent adverse events which occurred up to 42 days after the 18F fluciclovine administration
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 18F-Fluciclovine PET CT | Single intravenous administration of 18F-Fluciclovine for PET Scan 18F-Fluciclovine PET CT: Radioligand for PET CT scanning |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPLICATION SITE REACTION | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Gardiner MB ChB, MRCP, FFPM | Blue Earth Diagnostics, Ltd. | 1-781-552-3403 | P.Gardiner@blueearthDx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2018 | Aug 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2018 | Aug 9, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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PET Imaging study
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PSA levels in relation to scan positivity were analysed to determine the optimal PSA threshold for detecting recurrent prostate cancer by 18F fluciclovine PET/CT
| 1 month |
| Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT. | Safety was 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 18F fluciclovine injection throughout the study period. | 1 month |
| Oxford |
| Oxfordshire |
| OX3 7LE |
| United Kingdom |
| Royal Marsden Hospital | Sutton | Surrey | SM2 5PT | United Kingdom |
| St James Institute of Oncology | Leeds | Yorkshire | LS9 7TF | United Kingdom |
| Greater Glasgow & Clyde NHS Trust | Glasgow | United Kingdom |
| University College London Hospital | London | NW1 2BU | United Kingdom |
| St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| Scarsbrook AF, Bottomley D, Teoh EJ, Bradley KM, Payne H, Afaq A, Bomanji J, van As N, Chua S, Hoskin P, Chambers A, Cook GJ, Warbey VS, Han S, Leung HY, Chau A, Miller MP, Gleeson FV; FALCON study group. Effect of 18F-Fluciclovine Positron Emission Tomography on the Management of Patients With Recurrence of Prostate Cancer: Results From the FALCON Trial. Int J Radiat Oncol Biol Phys. 2020 Jun 1;107(2):316-324. doi: 10.1016/j.ijrobp.2020.01.050. Epub 2020 Feb 14. |
| 31624865 | Derived | Cook GJR. Performance of 18F-fluciclovine PET/MR in the evaluation of osseous metastases from castration-resistant prostate cancer. Eur J Nucl Med Mol Imaging. 2020 Jan;47(1):16-17. doi: 10.1007/s00259-019-04540-z. Epub 2019 Oct 17. No abstract available. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Full Range | cm |
|
| Weight | Median | Full Range | Kg |
|
| Body Mass Index | Median | Full Range | kg/m^2 |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Response Rate to Radical Salvage Therapy | To establish the proportion of patients who have a sustained response to radical salvage therapy. | Full Analysis Set | Posted | Count of Participants | Participants | 7 months |
|
|
|
| Secondary | PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR | PSA levels in relation to scan positivity were analysed to determine the optimal PSA threshold for detecting recurrent prostate cancer by 18F fluciclovine PET/CT | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of Detection Rate | 1 month |
|
|
|
| Secondary | Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT. | Safety was 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 18F fluciclovine injection throughout the study period. | Treatment-emergent Adverse Events | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 0 |
| 104 |
| 1 |
| 104 |
| 31 |
| 104 |
| FATIGUE | General disorders | MedDRA version 18.1 | Systematic Assessment |
|
| APPLICATION SITE ERYTHEMA | General disorders | MedDRA version 18.1 | Systematic Assessment |
|
| CATHETER SITE BRUISE | General disorders | MedDRA version 18.1 | Systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA version 18.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| PAROSMIA | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| RESTLESS LEGS SYNDROME | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA version 18.1 | Systematic Assessment |
|
| BIOPSY PROSTATE | Investigations | MedDRA version 18.1 | Systematic Assessment |
|
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA version 18.1 | Systematic Assessment |
|
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
|
| POST PROCEDURAL CONTUSION | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
|
| MELANOMA RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
|
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
|
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
|
| ELECTROCARDIOGRAM ABNORMAL | Investigations | MedDRA version 18.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
|
| NECK MASS | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Disease progression |
|
| Salvage therapy guided by 18F-fluciclovine |
|
|
| Salvage therapy not guided by 18F-fluciclovine |
|
|
|
| PSA Subgroup >0.5 to 1.0 (ng/mL) |
|
|
| PSA Subgroup >1.0 to 2.0 (ng/mL) |
|
|
| PSA Subgroup >2.0 to 5.0 (ng/mL) |
|
|
| PSA Subgroup >5.0 to 10.0 (ng/mL) |
|
|
| PSA Subgroup >10 (ng/mL) |
|
|
| TEAEs Definitely |
|