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Clinical Trials/EUCTR2015-003397-33-IT
EUCTR2015-003397-33-IT
Active, not recruiting
Phase 1

68Ga-PSMA HBED-PET/CT in the evaluation of the biochemical relapse in patients with a history of prostate cancer radically treated. - Ga PSMA

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 sites67 target enrollmentSeptember 19, 2018
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Conditionsprostate cancerMedDRA version: 20.0Level: LLTClassification code 10001186Term: Adenocarcinoma of prostateSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
prostate cancer
Sponsor
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
Enrollment
67
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients must have histologically or cytologically confirmed prostate cancer
  • •2\.aged \>18 years.
  • •3\.Radical treatment for prostate cancer (radiotherapy or surgery)
  • •4\.18F\-FMC PET/CT negative or doubtful
  • •5\.Patients with PSA progression defined as PSA \= 1,0 ng/mL and/or PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 1
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 30
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •1\.No hormonotherapy in the last 6 months
  • •2\.No radiotherapy in the last 6 months.
  • •3\.Patients with PSA \< 1\.0 ng/ml

Outcomes

Primary Outcomes

Not specified

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