Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer

NCT ID: NCT02578940

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-06-22

Brief 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

Detailed 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.

Conditions

Cancer of the Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm

Single intravenous administration of 18F-Fluciclovine for PET Scan

Group Type: EXPERIMENTAL

18F-Fluciclovine PET CT

Intervention Type: DRUG

Radioligand for PET CT scanning

Interventions

18F-Fluciclovine PET CT

Radioligand for PET CT scanning

Intervention Type: DRUG

Other Intervention Names

FACBC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Innovate UK

OTHER_GOV

Sponsor Role: collaborator

Syne Qua Non Limited

INDUSTRY

Sponsor Role: collaborator

IND 2 Results LLC

INDUSTRY

Sponsor Role: collaborator

Blue Earth Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fergus Gleeson, FRCP FRCR

Role: PRINCIPAL_INVESTIGATOR

The Oxford University Hospitals NHS Trust

Locations

Mount Vernon Cancer Centre, Mount Vernon Hospital

Northwood, Middlesex, United Kingdom

Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

St James Institute of Oncology

Leeds, Yorkshire, United Kingdom

Greater Glasgow & Clyde NHS Trust

Glasgow, , United Kingdom

University College London Hospital

London, , United Kingdom

St Thomas' Hospital

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37121865 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32068113 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31624865 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BED-004

Identifier Type: -

Identifier Source: org_study_id