Prostate cancer MedDRA version: 17.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [18F]-Fluorocholin inj.
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]- Fluorocholin
Other descriptive name: FLUOROMETHYL-(18F)-DIMETHYL-2-HYDROXYETHYL-AMMONIUM
C
Sponsors
Masarykuv onkologický ústav
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • age = 18 years • clinically localized/locally progressed prostate cancer- high risk group (clinical stage cT2c or higher or PSA higher than 20 ng/ml or Gleason score more than 8-10) before the planned curative therapy to exclude a metastatic impairment • examination of the disseminated prostate cancer to assess the impaired area • biochemical recidive after a radical treatment od prostate cancer to localise the recidive and eventually to plan a targeted local therapy • signed informed consent • ECOG PS 0-1 • Laboratory values: • bilirubin 50 x 109 / l • diagnostic CT examination of abdomen and pelvis performed max. 28 days prior to study PET examination • assessment of PSA max. 14 days prior to study PET examination, in case of relaps of the disease - assessment of PSA doubling time • Aa least 3 weeks from eventual last application of anticancer treatment and 6 weeks from eventual last radiotherapy (first 4 subjects should not by premedicated neither by chemotherapy nor by radiotherapy in order to restrict the possible infuence of those treatmensts on the quality of examinations) • ability to cooperate according to the requirements of protocol 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • hypersensitivity to any compound of the investigational medicinal product • renal impairment • urea > 1,5x maximum normal value • creatinine > 1,5x maximum normal value • presence of any psychical, familial, social or geographic obstacles which could cause noncompliance with the protocol. These facts must be discussed with the subject prior to his/her inclusion • weight more than 204 kg or deformity of thorax that could make the passage of the gantry of the device (diameter 70 cm) impossible • claustrophobia or incapacity to lie 20 minutes without moving
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove accumulation of the radiopharmaceutical medicinal product [18F]-Fluorocholin inj. administrated in the activity of 4 MBq / kg in the cancer tissue of prostate cancer and eventuual metastases. ;Secondary Objective: 1. Assessment of safety of the investigational medicinal product 2. Comparison of accumulation of the radiopharmaceutical medicinal product [18F]-Fluorocholin inj., image contrast (defined as relation of intensity of acumulation of the radiopharmaceutical medicinal product in the tumour to intensity of accumulation in body background) and diagnostic quality in early imaging (10 minutes after the application) and late imaging (60 minutes after the application). ;Primary end point(s): Proven accumulation of the radiopharmaceutical medicinal product [18F]-Fluorocholin inj. administrated in the activity of 4 MBq / kg in the cancer tissue of prostate cancer and eventuual metastases. ;Timepoint(s) of evaluation of this end point: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of safety of the investigational medicinal product 2. Comparison of accumulation of the radiopharmaceutical medicinal product [18F]-Fluorocholin inj., image contrast (defined as relation of intensity of acumulation of the radiopharmaceutical medicinal product in the tumor to intensity of accumulation in body background) and diagnostic quality in early imaging (10 minutes after the application) and late (60 minutes after the application). ;Timepoint(s) of evaluation of this end point: 1. During the whole clinical trial 2.10 minutes after the application and 60 minutes after the application | — |
Countries
Czech Republic
Contacts
Public ContactOddelení klinických hodnocení
Masarykuv onkologický ústav
Outcome results
None listed