PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers

Open-label, Multi Center PET/CT Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY1075553 Following a Single Intravenous Administration of 300 MBq in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers.

PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Diagnostic Imaging
• Intervention / Treatment: Drug: BAY1075553; Drug: BAY1075553

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4010
• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0028

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Part 1: Healthy volunteers only

  -- Males ≥ 40 years of age

• Part 2: Prostate cancer patients

  • Males ≥ 18 years of age
  • Serum PSA (Prostate-Specific Antigen) value above normal.
  • Patients had an MRI and/or a positive [11C] - or [18F] -choline PET/CT for primary diagnosis (Note: MRI and [11C]-or [18F]-choline PET/CT are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed
  • Patients with primary prostate cancer have to be scheduled for prostatectomy
  • In patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a Gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate
  • Patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included
• Part 3: Prostate cancer patients -- The criteria for eligibility of part 3 are identical to the ones of part 2. Except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis.

Exclusion Criteria:

• Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY1075553, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
• Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
• Active inflammatory bowel disease within the last 6 months
• Acute prostatitis requiring medical treatment within the last 6 months
• A non-urologic bacterial infection requiring active treatment with antibiotics within 3 months
• Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
• Patients with primary prostate cancer only: androgen ablation within 3 months before planned treatment
• Subject fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: BAY1075553; Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1; Drug: BAY1075553; Healthy volunteers for dosimetry, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
Experimental: Arm 2	Drug: BAY1075553; Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1; Drug: BAY1075553; Healthy volunteers for dosimetry, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety parameters, for example laboratory and electrocardiogram abnormalities	Day 2
Effective radiation dose given in mSv (milliSievert) in healthy volunteers	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall lesion detection rate	Day 1
Lesion detection rate in comparison to histology, where available (cancer lesion detection rate)	Day 1
Lesion detection rate in comparison to MRI (Magnetic Resonance Imaging) and/or [11C] (11Carbon)- or [18F] (18Fluor)-choline PET/CT (whenever available)	Day 1
Accumulation score in all lesions identified with BAY1075553	Day 1

Collaborators and Investigators

• Sponsor: Life Molecular Imaging SA

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 1, 2011
• First Posted (Estimate): February 2, 2011

Study Record Updates

• Last Update Posted (Estimate): January 21, 2013
• Last Update Submitted That Met QC Criteria: January 18, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Prostate cancer; Neoplasm; Diagnostic Imaging; PET (Positron Emission Tomography) -tracer; PET-diagnosis
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 15117 (Other Identifier: City of Hope Comprehensive Cancer Center); 2010-022031-11 (EudraCT Number)