A study on the ability of PET/CT conducted with administration of 64Cu(II)Cl2 in localising metastases from prostate cancer in patients with worsening disease, during treatment for deprivation of male sex hormones

Phase 1

• Conditions: metastatic prostate carcinoma; MedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001158-41-IT
• Lead Sponsor: SPARKLE SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1.age>=50 years at the time of enrollment (There is no upper age limit that contraindicate the diagnostic test)
2.documented previous histological diagnosis of primitive prostate adenocarcinoma
3.subject treated with ADT (orchiectomy, and/or LHRH agonists, and/or androgens antagonists)
4.previous clinical diagnosis of metastatic disease on bone, and/or lung, and/or lymphnode due to PCa (with involvement of pelvic region, and/or lumbar lymph node and/or sub phrenic), also documented with the restaging CT (See below)
5.recent disease progression (increase of PSA in serial determinations, and/or clinical progression and/or radiological), during ADT with clinical indication to restaging (also radiological)
6.availability of a Whole-body CT examination (with and without contrast medium), performed for restaging during the 20 days before the enrollment visit (slice thickness <5mm)
7.availability:
oa whole-body CT examination (with and without contrast medium), performed within the eight months before the enrollment visit (technically comparable whit the examination of restaging, particularly with slice thickness <5mm)
or:
oat least one of the following imaging tests relative to functional metabolic, performed for restaging on BSE clinically indicated, within 20 days prior to enrollment visit:
MRI (bone), 18F-FCH PET / CT,

8.negative clinical history for other past or in progress neoplastic diseases, with the exception of non-melanoma skin cancers
9.Karnofski index >80%
10.the absence of other significant co-morbidities (see: Exclusion criteria)
11.complete ability to understand the information reported in the trial informative leaflet for the subject
12.complete ability to sign the valid informed consent

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Anemia with Hb<10 gr/dL
2.Presence of symptoms or signs of sepsis and/or evidence of acute infection
3.AST >1.5 times the upper limit of the normal range
4.ALT >1.5 times the upper limit of the normal range
5.Total Bilirubin > 1.5 times the upper limit of the normal range
6.Clinical history and/or history of serological evidence for HBV infection
7.Clinical history and / or history of serological evidence for HCV infection
8.IRC more serious of stage II (GFR <60 ml/min calculated with MDRD equation)
9.TIA and stroke in the previous six months
10.Diagnosis of degenerative neurological disorder
11.Other chronic diseases of snc
12.Clinical history of psychiatric illness or use of psychotrope drug
13.Acute coronary syndrome in the previous six months
14.Heart failure with NYHA class> 1, or FE VS <50%, clinically documented
15.Valvular cardiopathy with indication for surgical correction
16.Chronic respiratory pathology with significant functional limitation
17.Diseases of copper metabolism (m.di Menkes, m.di Wilson)
18.Diabetes mellitus treated with insulin
19.Subjects treated with chemotherapy
20.Radiation therapy performed within the previous 120 days
21.Major surgery performed within the previous 120 days
22.BMI > 28
23.Previous participation in clinical trials with exposure to ionizing radiation for medical purposes
24.Occupational exposure to ionizing radiation
25.Any condition, material, logistical, or subjective, which, even in the opinion of the Principal Investigator, may affect the compliance of the subject to the execution of procedure provided in the Protocol
26.Inability to understand the information reported in the trial informative leaflet for the subject

Study & Design

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