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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01287845
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : January 21, 2013
Information provided by (Responsible Party):
Piramal Imaging SA

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

Condition or disease Intervention/treatment Phase
Diagnostic Imaging Drug: BAY1075553 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : February 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Experimental: Arm 2 Drug: BAY1075553
Healthy volunteers for dosimetry, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1

Primary Outcome Measures :
  1. Safety parameters, for example laboratory and electrocardiogram abnormalities [ Time Frame: Day 2 ]
  2. Effective radiation dose given in mSv (milliSievert) in healthy volunteers [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Overall lesion detection rate [ Time Frame: Day 1 ]
  2. Lesion detection rate in comparison to histology, where available (cancer lesion detection rate) [ Time Frame: Day 1 ]
  3. 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 ]
  4. Accumulation score in all lesions identified with BAY1075553 [ Time Frame: Day 1 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01287845

United States, Michigan
Ann Arbor, Michigan, United States, 48109-0028
Linz, Austria, 4010
Sponsors and Collaborators
Piramal Imaging SA
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Piramal Imaging SA Identifier: NCT01287845     History of Changes
Other Study ID Numbers: 15117
2010-022031-11 ( EudraCT Number )
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Piramal Imaging SA:
Prostate cancer
Diagnostic Imaging
PET (Positron Emission Tomography) -tracer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases