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
Primary Purpose
Diagnostic Imaging
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BAY1075553
BAY1075553
Sponsored by
About this trial
This is an interventional diagnostic trial for Diagnostic Imaging focused on measuring Prostate cancer, Neoplasm, Diagnostic Imaging, PET (Positron Emission Tomography) -tracer, PET-diagnosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Safety parameters, for example laboratory and electrocardiogram abnormalities
Effective radiation dose given in mSv (milliSievert) in healthy volunteers
Secondary Outcome Measures
Overall lesion detection rate
Lesion detection rate in comparison to histology, where available (cancer lesion detection rate)
Lesion detection rate in comparison to MRI (Magnetic Resonance Imaging) and/or [11C] (11Carbon)- or [18F] (18Fluor)-choline PET/CT (whenever available)
Accumulation score in all lesions identified with BAY1075553
Full Information
NCT ID
NCT01287845
First Posted
January 31, 2011
Last Updated
January 18, 2013
Sponsor
Life Molecular Imaging SA
1. Study Identification
Unique Protocol Identification Number
NCT01287845
Brief Title
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
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life Molecular Imaging SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnostic Imaging
Keywords
Prostate cancer, Neoplasm, Diagnostic Imaging, PET (Positron Emission Tomography) -tracer, PET-diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BAY1075553
Intervention Description
Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
Intervention Type
Drug
Intervention Name(s)
BAY1075553
Intervention Description
Healthy volunteers for dosimetry, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
Primary Outcome Measure Information:
Title
Safety parameters, for example laboratory and electrocardiogram abnormalities
Time Frame
Day 2
Title
Effective radiation dose given in mSv (milliSievert) in healthy volunteers
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Overall lesion detection rate
Time Frame
Day 1
Title
Lesion detection rate in comparison to histology, where available (cancer lesion detection rate)
Time Frame
Day 1
Title
Lesion detection rate in comparison to MRI (Magnetic Resonance Imaging) and/or [11C] (11Carbon)- or [18F] (18Fluor)-choline PET/CT (whenever available)
Time Frame
Day 1
Title
Accumulation score in all lesions identified with BAY1075553
Time Frame
Day 1
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0028
Country
United States
City
Linz
ZIP/Postal Code
4010
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
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
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