Detection of Prostate Cancer Lesions with Imaging Tracer for Positron Emission Tomography in Patients who have previously been treated for Prostate Cancer

Phase 1

• Conditions: Suspicion of prostate cancer recurrence or persistence 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 after radiotherapy or cryotherapy and/or greater than 0.2 ng/mL after prostatectomy; MedDRA version: 21.1Level: 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: 21.0Level: 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: EUCTR2020-004235-24-NL
• Lead Sponsor: ABX GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-16
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

1.Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy
2.Suspicion of recurrence or persistence
-- after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)
-- after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)
3. For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment.
4.Life expectancy of 6 months or more as judged by the investigator
5.Willing and able to undergo all study procedures
6.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) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1.Age: less than18 years
2.Contraindications to any of the ingredients of [18F]PSMA-1007
3.Close affiliation with the investigational site; e.g. first-degree relative of the investigator
4.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
5.Having been previously enrolled in this clinical trial
6.Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
7.Being clinically unstable or requiring emergency treatment
8.Patients who are unwilling to consider a biopsy if clinically recommended
9.Patients who are unable to undergo a PET/CT scan (e.g,, patients who are extremely obese, unable to lie flat or remain still, or have uncontrollable claustrophobia)
10.Patients for whom systemic therapy is the most likely course regardless of PET findings.

Study & Design

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