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

NCT01287845 | Completed Phase 1

• 2 other identifiers: 151172010-022031-11
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 2

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

Conditions

Diagnostic Imaging

Keywords

Prostate cancer; Neoplasm; Diagnostic Imaging; PET (Positron Emission Tomography) -tracer; PET-diagnosis

Outcome Measures

Primary Outcomes (2)

• Safety parameters, for example laboratory and electrocardiogram abnormalities

  Day 2

• Effective radiation dose given in mSv (milliSievert) in healthy volunteers

  Day 1

Secondary Outcomes (4)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: BAY1075553

Arm 2

EXPERIMENTAL

Drug: BAY1075553

Interventions

BAY1075553 DRUG

Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Life Molecular Imaging SA: lead

Study Sites (2)

Unknown Facility

Ann Arbor, Michigan, 48109-0028, United States

Location

Unknown Facility

Linz, 4010, Austria

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 2, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

US (1); AU (1)