Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2015-000625-37-GB
EUCTR2015-000625-37-GB
Active, not recruiting
Phase 1

A phase 3, open-label study to assess the clinical utility of fluciclovine (18F) PET/CT in patients with prostate cancer with biochemical recurrence after radical treatment - FALCON (Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of prostate cancer)

Blue Earth Diagnostics Limited0 sites180 target enrollmentApril 15, 2015
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsProstate cancer with biochemical recurrence after radical treatmentMedDRA version: 20.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prostate cancer with biochemical recurrence after radical treatment
Sponsor
Blue Earth Diagnostics Limited
Enrollment
180
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 15, 2015
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •(1\) The subject is a male \=18 years old.
  • •(2\) 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 BCR on the basis of:
  • •a. Post RRT / brachytherapy: Increase in PSA level \=2\.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO\-Phoenix criteria) \[53], or
  • •b. Post 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.
  • •(3\) The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
  • •(4\) The subject is being considered for radical salvage therapy.
  • •(5\) 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.
  • •(6\) The subject’s Eastern Cooperative Oncology Group \[ECOG] performance status 0\-2\.
  • •(7\) The subject should not have received androgen\-deprivation therapy within 3 months of screening.

Exclusion Criteria

  • •(1\) The subject has been previously included in this study.
  • •(2\) 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.
  • •(3\) The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents.
  • •(4\) The subject has had a choline PET/CT scan within 3 months of the screening visit.
  • •(5\) The subject has bilateral hip prostheses.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 3
Phase 3 Study for Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Boys and Girls
JPRN-jRCT2031210080Tanaka Yoshiyuki300
Active, not recruiting
Phase 1
Phase 3 Study for Immunogenicity and Safety of the 9vHPV Vaccine inJapanese Boys and GirlsPapillomavirus InfectionsMedDRA version: 20.0Level: HLGTClassification code 10047438Term: Viral infectious disordersSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10071146Term: Human papilloma virus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Immune system processes [G12]
EUCTR2020-001170-29-Outside-EU/EEAMerck Sharp & Dohme LLC
Active, not recruiting
Phase 1
A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).
EUCTR2015-001997-16-GBVertex Pharmaceuticals Incorporated35
Active, not recruiting
Phase 1
A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).
EUCTR2015-001997-16-IEVertex Pharmaceuticals Incorporated35
Active, not recruiting
Phase 1
A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).
EUCTR2015-001997-16-DEVertex Pharmaceuticals Incorporated57