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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02578940
Other study ID # BED-004
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2015
Est. completion date June 22, 2018

Study information

Verified date September 2019
Source Blue Earth Diagnostics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date June 22, 2018
Est. primary completion date May 17, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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:

1. Post radical radiotherapy (RRT) / brachytherapy: Increase in PSA level =2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) [53], or

2. Post radical prostatectomy (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.

- 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:

- The subject has been previously included in this study.

- 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.

- The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents.

- The subject has had a choline PET/CT scan within 3 months of the screening visit.

- The subject has bilateral hip prostheses.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
18F-Fluciclovine PET CT
Radioligand for PET CT scanning

Locations

Country Name City State
United Kingdom Greater Glasgow & Clyde NHS Trust Glasgow
United Kingdom St James Institute of Oncology Leeds Yorkshire
United Kingdom St Thomas' Hospital London
United Kingdom University College London Hospital London
United Kingdom Mount Vernon Cancer Centre, Mount Vernon Hospital Northwood Middlesex
United Kingdom Churchill Hospital Oxford Oxfordshire
United Kingdom Royal Marsden Hospital Sutton Surrey

Sponsors (4)

Lead Sponsor Collaborator
Blue Earth Diagnostics IND 2 Results LLC, Innovate UK, Syne Qua Non Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
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. 1 month
Secondary Response Rate to Radical Salvage Therapy To establish the proportion of patients who have a sustained response to radical salvage therapy. 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 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. 1 month
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