Imaging of the prostate tumors using PET/CT and PET/MRI with the ligand of the prostatic specific membrane antigene 68Ga-PSMA-11

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004128-32-CZ

Enrollment

200

Registered

2017-11-20

Start date

2017-12-01

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostatic carcinoma higly suspected or its staging or restaging

Interventions

Product Code: 68Ga-PSMA-11 Pharmaceutical Form: Radiopharmaceutical precursor, solution INN or Proposed INN: 68GA-PSMA HBED-CC Other descriptive name: 68GA-PSMA HBED-CC Concentration unit: Bq becquer

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: prostatic carcinoma higly suspected or its staging or restaging in male older than 18, WHO performance status 1 or 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: WHO performance status 3 or 4, renal mpairment

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): validation of the imaging protocol;Timepoint(s) of evaluation of this end point: early evaluation after 15 - 20 examinations, than intermediate after 50 , 100 and 150	—

Primary

Measure	Time frame
Main Objective: relation of the accumulation level with biological behavior of the tumorosu tissue, degree of the tumorou spread within an organism and serum levels of prostatic specific antigene;Secondary Objective: to validate imaging protocol;Primary end point(s): relation of the accumulation level with biological behavior of the tumorosu tissue, degree of the tumorou spread within an organism and serum levels of prostatic specific antigene;Timepoint(s) of evaluation of this end point: early evaluation after 15 - 20 examinations, than intermediate after 50 , 100 and 150	—

Measure

Time frame

Main Objective: relation of the accumulation level with biological behavior of the tumorosu tissue, degree of the tumorou spread within an organism and serum levels of prostatic specific antigene;Secondary Objective: to validate imaging protocol;Primary end point(s): relation of the accumulation level with biological behavior of the tumorosu tissue, degree of the tumorou spread within an organism and serum levels of prostatic specific antigene;Timepoint(s) of evaluation of this end point: early evaluation after 15 - 20 examinations, than intermediate after 50 , 100 and 150

—

Countries

Czech Republic

Contacts

Public ContactProf. MUDr. jirí Ferda, Ph.D.

Fakultní nemocnice Plzen

ferda@fnplzen.cz+420377103436

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026