Comparative study of a specific imaging biomarker, 68Ga-PSMA-11, and the standard imaging protocol with 18F-Fluorocholine in the detection of Recurrence in Prostate Cancer Patients

Phase 1

• Conditions: Prostate Cancer; MedDRA version: 20.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10066489 Term: Progression of prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10036917 Term: Prostate cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10036918 Term: Prostate cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unsp; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-003740-36-PT
• Lead Sponsor: ICNAS Produção Lda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-10
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

Patients that gave free written consent to participate in the study trough the Inform Consent Form;
¿ Patients willing to comply with all study procedures and show availability for the duration of the study;
¿ Men with age between 18 and 80 years old at time of enrolment;
¿ Patients diagnosed with prostate cancer that have followed a radical treatment by prostatectomy or radiotherapy;
o Biochemical relapse:
After surgery: the last two PSA measurements had values >0.2ng/ml.
After radiotherapy: PSA increase of 2.0ng/ml above the nadir.
o Residual disease:
After surgery: positive PSA level after surgery
After radiotherapy: two consecutive PSA measurements PSA>0.2 ng/ml (attention to false positives).
¿ Patients that have a prescription to perform a 18F-Fluorocholine PET/CT scan;
¿ Patients with PSA level <10 ng/ml at study inclusion;
¿ Patients with a life expectancy superior to 12 months;
¿ Patients considered for local salvage treatment
¿ Patients with an ECOG performance status ¿ 2;
¿ Patient under the National Healthcare System;
¿ Patients physically and psychologically able to participate in the study.
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 16

Exclusion Criteria

Patients presenting a known hypersensitivity to the active substance or any excipient of the investigational drug;
¿ Patients with known malignant disease, irrespectively of how long it has been diagnosed (with the exception of basal-cell carcinomas);
¿ Patients with alcohol or drug addiction, who have a serious illness, mental disorder or any other cause that could affect their participation in the study;
¿ Patients exposed to any investigational drug or device in the six months prior to the date of enrolment.

Study & Design

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