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| Name | Class |
|---|---|
| American College of Radiology | OTHER |
| IND 2 Results LLC | INDUSTRY |
| Syne Qua Non Limited | INDUSTRY |
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This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-fluciclovine PET CT | Experimental | Single intravenous administration of 18F-fluciclovine PET CT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-fluciclovine PET CT | Drug | Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT | 2-22 days post PET CT |
| Measure | Description | Time Frame |
|---|---|---|
| The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up. Investigators were instructed to assess any clinically significant change from the revised management plan. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Umar Mahmood, MD, PhD | Harvard Medical School (HMS and HSDM) | Study Chair |
| Peter Gardiner, MB ChB, MRCP, FFPM | Blue Earth Diagnostics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Cedars-Sinai Medical Center |
| 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. | |
| 31216198 |
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The study was conducted between 01 June 2016 (first patient, screening visit) and 01 November 2017 (last patient, last contact) at 17 sites in the USA. Overall 17 sites were initiated, of which 15 sites enrolled patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | 18F-fluciclovine PET CT | Single intravenous administration of 18F-fluciclovine PET CT. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 7, 2017 | Oct 31, 2018 |
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|
| The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population | The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT | 1 week |
| The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population | The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally | 1 week |
| The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy | Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI | 6 months |
| The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy | Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI | 6 months |
| Los Angeles |
| California |
| 90048 |
| United States |
| Tower Urology | Los Angeles | California | 90048 | United States |
| Genesis Research, LLC | San Diego | California | 92123 | United States |
| University of Florida | Jacksonville | Florida | 32209 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Roudebush VA Medical Center | Indianapolis | Indiana | 46202 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Coastal Urology Associates | Brick | New Jersey | 08724 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Urologic Consultants of SE Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Savir-Baruch B, Lovrec P, Solanki AA, Adams WH, Yonover PM, Gupta G, Schuster DM. Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer. AJR Am J Roentgenol. 2019 Oct;213(4):851-858. doi: 10.2214/AJR.19.21153. Epub 2019 Jun 19. |
| Received 18F-fluciclovine |
|
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | 18F-fluciclovine PET CT | Single intravenous administration of 18F-fluciclovine PET/CT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. | The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT | For the primary analysis population, of the 213 patients included in the EAS, 122 patients with a positive 18F-fluciclovine scan and 91 patients with a negative 18F-fluciclovine scan had a pre 18F-fluciclovine PET/CT treatment management plan. | Posted | Count of Participants | Participants | 2-22 days post PET CT |
|
|
| ||||||||||||||||||||||||||||
| Secondary | The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment | The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up. Investigators were instructed to assess any clinically significant change from the revised management plan. | 211 participants completed the study (actual treatment assessed at study completion). Results also presented by 18F-fluciclovine PET CT results. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population | The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT | Results presented for Full Analysis Set | Posted | Count of Participants | Participants | 1 week |
|
| |||||||||||||||||||||||||||||
| Secondary | The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population | The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally | Participants may have lesions detected in both regions (prostate/prostate bed and extra-prostatic). | Posted | Count of Participants | Participants | 1 week |
|
| |||||||||||||||||||||||||||||
| Secondary | The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy | Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI | Only scans graded as positive or negative by the adjudication panel were included in these calculations. | Posted | Number | 95% Confidence Interval | Percentage of scans | 6 months |
|
| ||||||||||||||||||||||||||||
| Secondary | The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy | Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI | Only scans graded as positive or negative by the adjudication panel were included in these calculations. | Posted | Number | 95% Confidence Interval | Percentage of scans | 6 months |
|
|
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 PET CT. | 0 | 213 | 0 | 213 | 44 | 213 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Excercise tolerance decreased | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Intervertrabral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Emotional disorder | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Blood creatine increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Carbon dioxide decreased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Waist circumference increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Breast tenderness | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
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| Gynaecomastia | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
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| Nipple pain | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
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| Scrotal irritation | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
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| Atrial fibrilation | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Hyperchloreamia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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Neither Institution nor Investigator will submit for publication or public disclosure any publication or disclosure based on the results of the Study until after the first to occur of (a) publication of the Multi-Center Clinical Trial results; (b) notification by Sponsor that the Multi-Center Clinical Trial submission is no longer planned; or (c) the eighteen (18) month anniversary of the completion or early termination of the Multi-Center Clinical Trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Gardiner MB ChB, MRCP, FFPM | Blue Earth Diagnostics, Ltd. | 1-781-552-3403 | P.Gardiner@blueearthDx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2018 | Oct 31, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Positive 18F-fluciclovine Scan |
|
|
| Negative 18F-fluciclovine Scan |
|
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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