Diagnostic feasibility of PET examination with use of [18F]-Fluorocholin inj. in patients with prostate carncer

Phase 1

• Conditions: Prostate cancer; MedDRA version: 17.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-005345-50-CZ
• Lead Sponsor: Masarykuv onkologický ústav

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-03
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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 < 1,5x maximum normal value
•creatinine < 1,5x maximum normal value
•urea < 1,5x maximum normal value
•trombocytes > 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

•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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br>;Secondary Objective: 1.Assessment of safety of the investigational medicinal product<br><br>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).<br>;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.<br>;Timepoint(s) of evaluation of this end point: 24 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Assessment of safety of the investigational medicinal product<br><br>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).<br>;Timepoint(s) of evaluation of this end point: 1. During the whole clinical trial<br>2.10 minutes after the application and 60 minutes after the application