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Clinical Trials/EUCTR2012-004297-26-IT
EUCTR2012-004297-26-IT
Active, not recruiting
Not Applicable

Phase III clinical study of PET-TC with [18f]Fluoroethyilcholine ([18f]Fech) in prostate cancer: assessment of the additional role with respec to conventional imaging techniques

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 sites750 target enrollmentOctober 16, 2012
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Conditionsprostate cancerMedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
prostate cancer
Sponsor
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Enrollment
750
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 16, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Eligibility Criteria

Inclusion Criteria

  • •\- adult male patients with a) known untreated prostate cancer (biopsy); b) biochemical recurrence of prostate cancer after prostatectomy (PSA\> 1 ng/ml or PSA doubling time \< 3 months); \- availability to participate to the study (informed consent); \- patients suitable for the diagnostic procedure (PET\-TC with 18F\-FECh);
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 150
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 600

Exclusion Criteria

  • •\- patients with recent diagnosis of prostate cancer who started hormone therapy; \- patients not suitable for the study protocol;

Outcomes

Primary Outcomes

Not specified

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