Prostate Cancer Clinical Trial

Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer

Summary

This study evaluates the diagnostic performance and safety of [18F]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy

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)
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.
Life expectancy of 6 months or more as judged by the investigator
Willing and able to undergo all study procedures
Informed consent in writing

Exclusion Criteria:

Age: less than18 years
Contraindications to any of the ingredients of [18F]PSMA-1007
Close affiliation with the investigational site
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
Having been previously enrolled in this clinical trial
Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
Being clinically unstable or requiring emergency treatment
Patients who are unwilling to consider a biopsy if clinically recommended
Patients who are unable to undergo a PET/CT scan
Patients for whom systemic therapy is the most likely course regardless of PET findings.

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

136

Study ID:

NCT04742361

Recruitment Status:

Active, not recruiting

Sponsor:

ABX advanced biochemical compounds GmbH

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 4 Locations for this study

See Locations Near You

Mayo Clinic
Rochester Minnesota, 55905, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Excel Diagnostics and Nuclear Oncology Center
Houston Texas, 77042, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
RUMC
Nijmegen , , Netherlands
Inselspital, Universitätsspital
Bern , , Switzerland

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

136

Study ID:

NCT04742361

Recruitment Status:

Active, not recruiting

Sponsor:


ABX advanced biochemical compounds GmbH

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.