PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Bombesin.

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.

It had two arms (groups): Arm 1 (experimental) and Arm 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 19 actual participants took part.

It was open to men only aged from 45 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males, \>/=50 and \</= 65 years of age. Males \>/= 45 years of age. The prostate cancer is histologically confirmed and results of histology are available. Patients with primary prostate cancer: \>/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation. Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.

The full record lists 8 inclusion and 2 exclusion criteria; among the exclusions: known sensitivity to the study drug or components of the preparation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Bombesin group and the comparison group should start out alike.

The Bombesin group and the comparison group ran side by side rather than switching.

Everyone knew when Bombesin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-11 with completion listed for 2011-11.

It ran at 3 sites in Finland (1), Germany (1) and Switzerland (1).

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Visual assessment of lesions (time frame: Day of study drug administration).

It also tracked 7 secondary outcomes, for example Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs), Blood pressure, Serum protein, Serum creatinine, Serum GOT (Glutamat-Oxalacetat-Transaminase) and Adverse events collection.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Bombesin in 19 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Bombesin compound page, all human trials.