Prostate CancerPhase 3LOCATENCT02680041
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
A Phase 3 study testing 18F-fluciclovine PET CT in people with Prostate Cancer, run by Blue Earth Diagnostics at 17 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 18F-fluciclovine PET CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Jun 2016to 1 Nov 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
- Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
- Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
- Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
- Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
- Being considered for salvage therapy
Show all 9Show fewer
- Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
- Previous brachytherapy treatment will have occurred at least 2 years in the past
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
- Androgen deprivation therapy (ADT) in the past 3 months
- History of bilateral orchidectomy
- Inability to tolerate 18F-fluciclovine PET/CT
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Urologic Consultants of SE Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Coastal Urology Associates
Brick, New Jersey, 08724
City of Hope National Medical Center
Duarte, California, 91010
Roudebush VA Medical Center
Indianapolis, Indiana, 46202
University of Florida
Jacksonville, Florida, 32209
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Tower Urology
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
Loyola University Medical Center
Maywood, Illinois, 60153
Manhattan Medical Research
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Genesis Research, LLC
San Diego, California, 92123
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment
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.
- Conditions
- Prostate Cancer
- Being tested
- 18F-fluciclovine PET CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluciclovine PET CTDrug
Also called FACBC
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
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluciclovine PET CT | Experimental | Single intravenous administration of 18F-fluciclovine PET CT. Receives: Drug: 18F-fluciclovine PET CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2-22 days post PET CT
Secondary outcomes (5)
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.
Measured: 6 months
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blue Earth Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology, IND 2 Results LLC, Syne Qua Non Limited
- Responsible party
- Sponsor
- Investigators
- Umar Mahmood, MD, PhD, Study chair, Harvard Medical School (HMS and HSDM)Peter Gardiner, MB ChB, MRCP, FFPM, Study director, Blue Earth Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680041
- Sponsor's protocol ID
- BED003
- Acronym
- LOCATE
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2016
- Last updated
- 28 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37121865Savir-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.
PubMed 31216198
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment
- ClinicalTrials.gov ID
- NCT02680041
- Acronym / sponsor ID
- LOCATE / BED003
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Blue Earth DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- American College of Radiology, IND 2 Results LLC, Syne Qua Non Limited
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-fluciclovine PET CT | Experimental | Drug: 18F-fluciclovine PET CTSingle intravenous administration of 18F-fluciclovine PET CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
- Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
- Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
- Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
- Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
Key exclusion criteria (4 listed)
- Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
- Androgen deprivation therapy (ADT) in the past 3 months
- History of bilateral orchidectomy
- Inability to tolerate 18F-fluciclovine PET/CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluciclovine PET CTAlso: FACBCSubjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment | Drug | 18F-fluciclovine PET CT |
Primary outcome
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
Time frame: 2-22 days post PET CT
The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
5 secondary outcomes
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
Time frame: 6 months
The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37121865Andriole 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.
- Derived from this study: PubMed 31216198Savir-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umar Mahmood, MD, PhD study chair
Harvard Medical School (HMS and HSDM)
Peter Gardiner, MB ChB, MRCP, FFPM study director
Blue Earth Diagnostics
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F-fluciclovine PET CT in people with Prostate Cancer, run by Blue Earth Diagnostics at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease. (time frame: 2-22 days post PET CT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02680041, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.