Comparison of 2 Imaging Tracers in Positron Emission Tomography for patients with prostate cancer

Phase 1

• Conditions: Suspicion of prostate cancer recurrence after previous definitive treatment, based on American Society for Radiation Oncology (ASTRO) criteria of 3 consecutive PSA rises and/or ASTRO/Phoenix criteria of PSA nadir above 2.0 ng/mL afterradiotherapy or cryotherapy and/or greater than 0.2 ng/mL after prostatectomy; MedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2018-002975-16-FR
• Lead Sponsor: ABX GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-20
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 188

Inclusion Criteria

1. male with original diagnosis of prostate carcinoma with prior definitive therapy
2. suspicion of recurrence
3. life expectancy of 6 months or more as judged by the investigator
4. willing and able to undergo all study procedures
5. informed consent in writing (dated and signed)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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 88

Exclusion Criteria

1. age: less than18 years
2. contraindications for F-18-Fluorocholine
3. contraindications for any of the ingredients of F-18-PSMA-1007
4. close affiliation with the investigational site; e.g. first-degree relative of the investigator
5. at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
6. having been previously enrolled in this clinical trial
7. mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
8. being clinically unstable or requiring emergency treatment

Study & Design

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