A Phase 2, Open-label Study to Assess the Uptake and Retention and Safety of GE 148 (18F) Injection in Subjects with Biopsy-proven Prostate Cancer who are Scheduled for Radical Prostatectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018311-15-SE

Enrollment

Registered

2010-04-29

Start date

2010-05-21

Completion date

Unknown

Last updated

2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detection of abnormal amino acid transport using Positron Emission Tomography (PET) in malignancy

Interventions

Product Name: GE-148 (18F) Injection Product Code: GE-148 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1)The subject is a male and is =18 years old. (2)The subject is scheduled to undergo radical prostatectomy with or without pelvic lymphadenectomy within 6 weeks of imaging with GE-148 (18F) Injection. (3)The subject has biopsy-proven prostate cancer with a minimum of 2 (if =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: (1)The subject has received chemotherapy, hormonal therapy or radiation therapy for prostate cancer. (2)A biopsy has been obtained from the prostate within the 6 weeks before enrolment. (3)The subject has been previously included in this study. (4)The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 week after administration of GE-148 (18F) Injection.

Design outcomes

Primary

Measure	Time frame
Main Objective: To differentiate the uptake and retention of GE-148 (18F) Injection between malignant prostate tumours, non malignant prostate pathology and normal prostate tissue, in subjects with prostate cancer.;Secondary Objective: (1)To assess the relationship between the uptake and retention of GE-148 (18F) Injection in malignant prostate tumours and their Gleason Score. (2)To assess the relationship between the uptake and retention of GE-148 (18F) Injection with quantitative assessments of AATs and Ki-67 expression in malignant prostate tumours, non malignant prostate pathology, and normal prostate tissue. (3)To assess the relationship between the uptake and retention of GE-148 (18F) Injection with quantitative assessments of AATs and Ki-67 expression in surgically removed pelvic lymph nodes showing uptake and retention of GE-148 (18F) Injection, where available. (4)To assess the ability of GE-148 (18F) Injection to detect the number of discrete malignant prostate tumours confirmed by histopathology. (5)To assess the safety of a single chemical dose of GE-148 (18F) Injection in subjects with prostate cancer. ;Primary end point(s): Uptake and retention of GE-148 (18F) Injection in malignant prostate tumours, non malignant prostate pathology and normal prostate tissue, calculated as SUVs (SUVmax early, SUVmax late, SUVR [ratio to SUVmean of reference tissue]).	—

Measure

Time frame

Main Objective: To differentiate the uptake and retention of GE-148 (18F) Injection between malignant prostate tumours, non malignant prostate pathology and normal prostate tissue, in subjects with prostate cancer.;Secondary Objective: (1)To assess the relationship between the uptake and retention of GE-148 (18F) Injection in malignant prostate tumours and their Gleason Score. (2)To assess the relationship between the uptake and retention of GE-148 (18F) Injection with quantitative assessments of AATs and Ki-67 expression in malignant prostate tumours, non malignant prostate pathology, and normal prostate tissue. (3)To assess the relationship between the uptake and retention of GE-148 (18F) Injection with quantitative assessments of AATs and Ki-67 expression in surgically removed pelvic lymph nodes showing uptake and retention of GE-148 (18F) Injection, where available. (4)To assess the ability of GE-148 (18F) Injection to detect the number of discrete malignant prostate tumours confirmed by histopathology. (5)To assess the safety of a single chemical dose of GE-148 (18F) Injection in subjects with prostate cancer. ;Primary end point(s): Uptake and retention of GE-148 (18F) Injection in malignant prostate tumours, non malignant prostate pathology and normal prostate tissue, calculated as SUVs (SUVmax early, SUVmax late, SUVR [ratio to SUVmean of reference tissue]).

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Countries

Denmark, Finland, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026