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

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10001186Term: Adenocarcinoma of prostateSystem Organ Class: 100000004864; prostate cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003397-33-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 67

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
F.1.3.1 Number of subjects for this age range 37

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified