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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01287845
First received: January 31, 2011
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Diagnostic Imaging
Drug: BAY1075553
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Safety parameters, for example laboratory and electrocardiogram abnormalities [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
  • Effective radiation dose given in mSv (milliSievert) in healthy volunteers [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall lesion detection rate [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Lesion detection rate in comparison to histology, where available (cancer lesion detection rate) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Accumulation score in all lesions identified with BAY1075553 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287845

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

Additional Information:
No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01287845     History of Changes
Other Study ID Numbers: 15117, 2010-022031-11
Study First Received: January 31, 2011
Last Updated: January 18, 2013
Health Authority: Austria: Agency for Health and Food Safety
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014